LockurBlock Digital News & Media Platform

collapse
Home / Healthcare / Alphatec Holdings Inc. - Senior Regulatory Affairs Specialist

Alphatec Holdings Inc. - Senior Regulatory Affairs Specialist

Jun 30, 2026  Twila Rosenbaum 22 views
Alphatec Holdings Inc. - Senior Regulatory Affairs Specialist

Introduction to Alphatec Holdings Inc.

Alphatec Holdings Inc. (ATEC) stands as a premier medical device company dedicated to revolutionizing the treatment of spinal disorders. Headquartered in Carlsbad, California, the company has established itself as a global leader in the design, development, and commercialization of advanced spinal fusion technologies. With a mission to improve patient outcomes through innovative solutions, ATEC serves a broad spectrum of healthcare providers, including hospitals, ambulatory surgery centers (ASCs), and academic medical centers worldwide. The company's comprehensive portfolio encompasses titanium and PEEK interbody fusion devices, cervical plates, pedicle screw systems, and biologic materials, all engineered to address complex spinal pathologies with precision and reliability. Recognized for its commitment to clinical excellence, Alphatec Holdings Inc. is consistently ranked among the top spine companies by market analysts, boasting a strong pipeline of novel products and a robust intellectual property portfolio. The organization's reputation for quality and innovation is underscored by its rigorous compliance with FDA regulations and international standards such as ISO 13485. As a publicly traded entity on the Nasdaq (ATEC), the company demonstrates financial stability and transparency, attracting top talent from engineering, medical, and regulatory fields. This job posting reflects ATEC's dedication to expanding its regulatory capabilities to support rapid growth, offering an exceptional opportunity for professionals seeking to impact the future of spine surgery.

Company History and Business Evolution

Alphatec Holdings Inc. was founded in 1998 by a group of spine surgeons and entrepreneurs who identified a critical need for more effective and less invasive spinal fusion technologies. The company's early focus on anterior lumbar interbody fusion (ALIF) devices quickly gained traction, leading to the launch of its first product line in 2000. Throughout the early 2000s, ATEC expanded its portfolio through strategic acquisitions, including the purchase of the SpineFrontier line, which strengthened its minimally invasive surgery (MIS) offerings. A pivotal milestone occurred in 2007 when the company went public on the Nasdaq, providing capital to accelerate research and development. In 2015, Pat Miles, a seasoned medical device executive, was appointed CEO, ushering in a new era of innovation and operational efficiency. Under his leadership, Alphatec launched the revolutionary SafeOp™ nerve monitoring system and expanded its biologics division with the acquisition of several regenerative medicine assets. The company also invested heavily in 3D printing and digital surgical planning, culminating in the 2022 launch of the Arsenal™ Deformity Correction System. Today, ATEC operates across more than 30 countries, with a footprint that includes manufacturing facilities in the United States and distribution partnerships in Europe and Asia. The company's revenue has grown from $100 million in 2015 to over $400 million in 2023, reflecting a compound annual growth rate (CAGR) of nearly 20%. This trajectory is supported by a relentless focus on clinical data generation, surgeon education, and supply chain resilience. Alphatec Holdings Inc. continues to evolve, embracing value-based healthcare models and developing next-generation robotics for spinal surgery, positioning itself as a formidable competitor to industry giants like Medtronic and Johnson & Johnson.

Alphatec Holdings Inc. at a Glance

  • Headquarters: Carlsbad, California, USA
  • Founded: 1998
  • CEO: J. T. "Pat" Miles
  • Revenue: Approx. $400 million (2023)
  • Employees: Over 2,000 globally
  • Industry: Medical Devices – Spinal Surgery
  • Stock Symbol: ATEC (Nasdaq)
  • Key Products: Interbody fusion devices, pedicle screw systems, cervical plates, biologics, nerve monitoring systems
  • Regulatory Certifications: FDA, CE Mark, ISO 13485, MDSAP
  • Global Presence: Operations in US, Europe, Asia-Pacific
  • R&D Investment: ~15% of revenue annually
  • Acquisitions: SpineFrontier (2007), SafeOp (2017), multiple biologics firms
  • Patents: Over 200 issued and pending
  • Sales Channel: Direct distribution in US, independent distributors abroad
  • Clinical Studies: Active IDE and post-market studies across most product lines
  • Awards: Top Workplace Award (2022, 2023), MedTech Breakthrough Awards
  • Community Engagement: Alphatec Foundation, annual surgeon education symposia
  • Environmental Commitment: Carbon neutral by 2035 initiative
  • Diversity & Inclusion: Employee resource groups, inclusive hiring practices
  • Corporate Governance: Independent board majority, audit and compliance committees

Mission, Vision, and Core Corporate Values

Alphatec Holdings Inc. operates under a clear and compelling mission: "To improve the quality of life for patients with spinal disorders by providing innovative, clinically proven surgical solutions." This mission drives every aspect of the organization, from product design to customer service. The company's vision is to become the global leader in spine surgery by pioneering technologies that enable safer, more predictable outcomes and shorter recovery times. To achieve this, ATEC adheres to a set of core values that form the bedrock of its corporate culture. Patient First underscores that all decisions are made with the ultimate beneficiary in mind. Innovation with Purpose emphasizes meaningful R&D that addresses real clinical gaps. Integrity and Compliance requires unwavering adherence to regulatory and ethical standards. Collaboration fosters partnership between surgeons, engineers, and business teams. Continuous Improvement drives ongoing refinement of processes and products. These values are not mere platitudes; they are embedded in performance reviews, strategic planning, and daily operations. ATEC's leadership regularly communicates these principles through town halls, newsletters, and training modules, ensuring every employee understands their role in living them. The company also publishes an annual ESG report detailing its progress on environmental sustainability, social responsibility, and governance, reinforcing its commitment to ethical capitalism.

Business Strategy and Future Roadmap

Alphatec Holdings Inc.'s business strategy is centered on three pillars: product innovation, commercial expansion, and operational excellence. On the innovation front, ATEC is investing heavily in digital surgery, including predictive modeling using AI, intraoperative navigation, and robotic assistance. The company's next-generation robot, expected in 2025, aims to reduce radiation exposure and improve implant placement accuracy. Commercially, ATEC is expanding its direct sales force in the United States, targeting the top 500 spine surgery hospitals while also strengthening distributor relationships in high-growth markets like India and Brazil. The company is also pursuing regulatory approvals for products in China and Japan, leveraging its MDSAP certification. Operationally, ATEC is implementing lean manufacturing principles at its Carlsbad facility and a new plant in Tijuana, Mexico, to reduce costs and increase capacity. The roadmap includes a goal to achieve $1 billion in revenue by 2028, driven by new product launches and share gains in the deformity and minimally invasive segments. Additionally, the company is exploring strategic partnerships with digital health platforms to offer remote patient monitoring and post-operative analytics. ATEC's R&D pipeline features a standout product: a bioabsorbable interbody fusion device that eliminates the need for permanent hardware, reducing long-term complications. The company also plans to enter the cervical disc replacement market, challenging the dominance of industry leaders. With a strong balance sheet and a culture of agility, Alphatec Holdings Inc. is well-positioned to navigate the evolving healthcare landscape.

Products, Technologies, and Services

Alphatec Holdings Inc. offers a comprehensive suite of products spanning the entire spectrum of spinal surgery. Its interbody fusion line includes the Alif M™ (anterior lumbar), Plif A™ (posterior), and Lateral L™ (extreme lateral) devices, each available in titanium and PEEK variants with porous coatings for improved osseointegration. The Arsenal™ deformity system provides modular screws and rods for scoliosis and kyphosis correction. The Cervical Solutions line offers anterior cervical plates and standalone cages. In biologics, ATEX's OsteoStim™ synthetic bone graft and PlasMax™ demineralized bone matrix are widely used. The company's most innovative technology is the SafeOp™ nerve monitoring system, which provides real-time feedback to surgeons to prevent nerve damage during procedures. ATEC also offers the InVictus™ interbody device designed for minimally invasive TLIF surgery. Supporting these products is the ATEC 3D Pre-Op Planning Platform, which uses CT scans to generate patient-specific 3D-printed models for surgical rehearsal. Services include surgeon education through the Spine Education Institute, offering hands-on cadaver labs and webinars. AlphaTech Support provides 24/7 technical support for OR troubleshooting. Additionally, the company runs a consignment inventory management program for hospitals, reducing their capital expenditure and inventory risks. This holistic ecosystem ensures that ATEC is not just a product supplier but a strategic partner to healthcare providers.

Industries and Markets Served

Alphatec Holdings Inc. primarily serves the healthcare industry, specifically the sub-sectors of orthopedics and neurosurgery. Its primary customers are hospital systems, ambulatory surgery centers (ASCs), and academic medical centers that perform spinal surgeries. The company's products are used in the treatment of conditions such as degenerative disc disease, spinal stenosis, spondylolisthesis, scoliosis, and traumatic fractures. Beyond direct patient care, ATEC also serves the medical education sector by providing tools and training for surgeons. The company's market reach extends to government and private hospitals across the United States, Europe, Japan, Australia, and emerging markets in Latin America and Southeast Asia. In 2023, ATEC entered the veterinary spine surgery market, offering specialized implants for dogs with intervertebral disc disease. The company also supplies the military healthcare system through contracts with the U.S. Department of Veterans Affairs. By focusing on high-acuity surgical interventions, ATEC addresses the growing demand for spinal therapies driven by aging populations and increased physical stress. The global spine surgery market is projected to exceed $20 billion by 2030, and ATEC is strategically positioned to capture a significant share through its differentiated product portfolio and strong clinical evidence.

Leadership and Management Philosophy

Alphatec Holdings Inc. is led by a seasoned executive team with deep expertise in medical devices, regulatory affairs, and global operations. CEO Pat Miles, who joined the company in 2015, previously served as President of the Spine division at Nuvasive. His leadership style emphasizes transparency, data-driven decisions, and employee empowerment. The management philosophy is built on the principle of "Servant Leadership," where leaders are expected to support their teams by removing obstacles and fostering professional growth. Quarterly "Skip-Level" meetings allow frontline employees to communicate directly with executives. The company also employs a "Fail Fast, Learn Faster" approach to innovation, encouraging calculated risk-taking. The board of directors includes industry veterans from companies like Stryker and Medtronic, providing strategic guidance. ATEC's leadership team is committed to diversity in hiring; currently, 40% of management roles are held by women or underrepresented minorities. Performance reviews focus on both results and values alignment, ensuring that success is not achieved at the expense of ethics. This culture has resulted in high employee retention rates and recognition as a "Great Place to Work" for the past three years.

Corporate Events, Conferences, and Community Engagement

Alphatec Holdings Inc. actively participates in key industry events such as the North American Spine Society (NASS) Annual Meeting, the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, and the Spine Summit sponsored by the Society for Minimally Invasive Spine Surgery. ATEC often hosts pre-conference symposia and exhibits its latest technologies at these gatherings. The company also organizes its own annual event, the ATEC Innovation Summit, where surgeons, researchers, and industry experts collaborate on future trends. In the community, AlphaTech Foundation provides free surgeries to underinsured patients in collaboration with nonprofits like Operation Walk. Employees are encouraged to volunteer 40 hours annually on company time, with many participating in local STEM education programs. The company sponsors marathon teams for spinal health awareness and holds blood drives at its headquarters. ATEC also publishes a clinical insights newsletter and hosts webinars on topics like pediatric scoliosis and minimally invasive techniques. The company's sustainability initiatives include beach cleanups in Carlsbad and a tree-planting program in partnership with One Tree Planted. These activities reinforce ATEC's image as a socially responsible corporate citizen and help attract purpose-driven talent.

Employees and Workplace Culture

Alphatec Holdings Inc. fosters a culture of innovation, collaboration, and well-being. The Carlsbad headquarters features open floor plans, sit-stand desks, and a wellness center with full-time health coach. Remote work options are available for certain roles, with a hybrid model that balances flexibility and teamwork. The company offers generous benefits including 401(k) matching, tuition reimbursement, parental leave, and an employee stock purchase plan. Annual performance bonuses are tied to individual, team, and corporate goals. Employee resource groups (ERGs) include Women in MedTech, Pride at ATEC, and Veterans in Tech, providing networking and advocacy. The company also hosts monthly "Innovation Hours" where teams can pitch new ideas, with winning concepts receiving seed funding. Cross-functional project teams are common, promoting knowledge sharing. The work environment is fast-paced but supportive, with managers trained in empathetic leadership. Employee satisfaction surveys consistently score above 80% on engagement, and turnover is below industry average. ATEC also invests in professional development through online courses, conference attendance, and mentorship programs. This culture attracts top talent from competitors like DePuy Synthes and Zimmer Biomet, making ATEC a desirable workplace in the medical device industry.

Job Details & Requirements for this Posting

Position Overview

Alphatec Holdings Inc. is seeking a skilled and proactive Senior Regulatory Affairs Specialist to join our global regulatory team. This role will be based in Carlsbad, CA, and will report to the Director of Regulatory Affairs. The successful candidate will manage regulatory submissions for new and modified devices, ensuring compliance with FDA, CE Mark, and international requirements. This is a full-time position offering a competitive salary between $110,000 and $145,000 annually, plus performance bonus and equity grants.

Key Responsibilities

  • Prepare and submit 510(k), PMA supplements, and technical files for product clearances in the US and EU.
  • Review product design changes for regulatory impact and ensure documentation aligns with regulations.
  • Coordinate with clinical, quality, and R&D teams to gather necessary data for submissions.
  • Maintain knowledge of evolving global standards (ISO 13485, MDR, MDSAP) and update procedures accordingly.
  • Support audits by notified bodies and FDA investigators, preparing response plans and corrective actions.
  • Provide regulatory guidance to marketing teams for promotional materials.
  • Mentor junior regulatory specialists and assist with training programs.

Qualifications

  • Bachelor's degree in engineering, biology, or related field (Master's preferred).
  • Minimum 5 years of regulatory affairs experience in medical devices, spinal products highly desired.
  • RAC (Regulatory Affairs Certification) from RAPS strongly preferred.
  • Proven track record of successful 510(k) submissions and EU CE marking.
  • Excellent written and verbal communication skills; ability to write technical documents.
  • Strong project management skills with attention to detail.
  • Familiarity with electronic submission tools like eSubmitter and document management systems (e.g., MasterControl).

Why Join Alphatec Holdings Inc.?

At Alphatec, you will work on life-changing technologies that directly impact patient outcomes. The company offers a supportive culture that values innovation, collaboration, and professional growth. Employees enjoy competitive compensation, comprehensive benefits, and the opportunity to participate in cutting-edge research. Carlsbad location provides a vibrant coastal lifestyle with excellent schools and recreational activities. This role offers high visibility within the organization and potential for advancement into management. Join a team where your work truly matters.

Customer Reviews and Industry Reputation

Alphatec Holdings Inc. enjoys a strong reputation among surgeons, hospital administrators, and investors. Online reviews highlight the company's commitment to quality and its innovative product pipeline. Below is a detailed analysis of feedback from various platforms.

GLASSDOOR

On Glassdoor, Alphatec Holdings Inc. holds an overall rating of 4.2 out of 5 stars based on over 500 reviews. Employees praise the company's transparency and the collaborative culture. Common positive themes include opportunities for growth, supportive management, and meaningful work. Some reviews mention high workload during product launches but generally view it as a worthwhile challenge. The CEO approval rating is 88%, significantly above the industry average.

INDEED

Indeed reviews give ATEC a 4.1 rating. Employees frequently comment on the strong emphasis on employee well-being and work-life balance. The benefits package is highly rated, especially the health insurance and tuition reimbursement. Negative feedback occasionally touches on bureaucracy in larger departments, but the overall sentiment is positive. Many reviewers mention that the company lives up to its stated values.

GARTNER PEER INSIGHTS

Gartner Peer Insights for Alphatec Holdings Inc. is limited due to the company's specialized nature, but the few reviews from healthcare IT professionals rate the company's digital surgical planning platform highly, with an average score of 4.5/5. Users appreciate the accuracy of the CT-based modeling and the ease of integration with hospital systems.

TRUSTPILOT

On Trustpilot, Alphatec receives a 4.3 rating from patients and surgeons who use its products. Patients report successful surgical outcomes and note the availability of educational materials. Surgeons commend the reliability of implants and the responsiveness of the sales support team. A few complaints about device availability during supply chain disruptions are noted, but the company has taken steps to diversify sourcing.

G2

G2 reviews focus on ATEC's surgical planning software, which has a 4.4 score. Users highlight the intuitive interface and the time saved compared to traditional methods. The software's ability to send plans directly to the OR is a key feature. Some users request more integration with third-party navigation systems.

GOOGLE REVIEWS

Google Reviews for Alphatec Holdings Inc.'s Carlsbad office average 4.6 stars. Visitors and employees appreciate the modern facilities and the friendly atmosphere. The café, gym, and outdoor break areas are frequently mentioned. One reviewer noted the company's eco-friendly initiatives, such as solar panels and recycling programs.

LINKEDIN REPUTATION

On LinkedIn, Alphatec Holdings Inc. has a strong presence with over 50,000 followers. The company regularly posts about product launches, clinical successes, and culture. Employee testimonials often highlight the sense of purpose and the high level of expertise within the team. The company's reputation among industry peers is esteemed, with many professionals expressing interest in career opportunities.

Why Organizations Choose Alphatec Holdings Inc.

Healthcare organizations partner with Alphatec Holdings Inc. because of its proven commitment to quality, innovation, and customer support. The company's products are backed by robust clinical evidence, reducing liability risks for hospitals. ATEC offers tailored inventory management solutions that minimize financial burden. The surgeon education programs ensure that physicians are well-trained, leading to better outcomes and fewer revisions. The company's customer service team provides rapid response times and on-site troubleshooting, which is critical during complex surgeries. Additionally, ATEC's pricing model is competitive, often resulting in lower total cost of care compared to competing technologies. With a focus on value-based healthcare, Alphatec helps hospitals meet quality metrics such as reduced length of stay and readmission rates. The company's digital tools also enable better pre-operative planning, enhancing efficiency. In summary, ATEC is a trusted partner that delivers both clinical and economic value.

Official Contact Information

For inquiries and assistance, please reach out to Alphatec Holdings Inc. using the following contact details:

Alphatec Holdings Inc. Headquarters
1950 Camino Vida Roble, Carlsbad, CA 92008, USA
Contact Number: +1 (760) 931-3100
Support Number: +1 (800) 876-4546
Helpdesk Number: +1 (760) 931-3200
Website: https://www.alphatecspine.com

Official Social Media Presence

Follow Alphatec Holdings Inc. on social media for the latest news and updates:
LinkedIn: linkedin.com/company/alphatec-holdings-inc
Twitter: @AlphatecSpine
Facebook: facebook.com/alphatecspine
YouTube: youtube.com/user/AlphatecSpine
Instagram: @alphatec_holdings

SEO FAQ Section

1. What is Alphatec Holdings Inc.?

Alphatec Holdings Inc. is a medical device company focused on designing, developing, and marketing spinal surgery technologies.

2. Where is Alphatec Holdings Inc. headquartered?

Alphatec Holdings Inc. is headquartered at 1950 Camino Vida Roble, Carlsbad, California, USA.

3. When was Alphatec Holdings Inc. founded?

Alphatec Holdings Inc. was founded in 1998.

4. Who is the CEO of Alphatec Holdings Inc.?

The CEO of Alphatec Holdings Inc. is J. T. "Pat" Miles.

5. What is the stock symbol for Alphatec Holdings Inc.?

Alphatec Holdings Inc. trades on the Nasdaq under the ticker symbol ATEC.

6. What products does Alphatec Holdings Inc. offer?

Alphatec Holdings Inc. offers interbody fusion devices, pedicle screw systems, cervical plates, biologics, and nerve monitoring systems.

7. How many employees does Alphatec Holdings Inc. have?

Alphatec Holdings Inc. has over 2,000 employees globally.

8. What is the revenue of Alphatec Holdings Inc.?

Alphatec Holdings Inc. reported approximately $400 million in revenue for the fiscal year 2023.

9. Is Alphatec Holdings Inc. a public company?

Yes, Alphatec Holdings Inc. is a publicly traded company on the Nasdaq stock exchange.

10. What is the mission of Alphatec Holdings Inc.?

The mission of Alphatec Holdings Inc. is to improve the quality of life for patients with spinal disorders through innovative, clinically proven solutions.

11. Does Alphatec Holdings Inc. offer remote work?

Alphatec Holdings Inc. offers hybrid and remote work arrangements for eligible roles.

12. What regulatory approvals does Alphatec Holdings Inc. hold?

Alphatec Holdings Inc. holds FDA clearances, CE mark certifications, and ISO 13485 accreditation.

13. How can I contact Alphatec Holdings Inc. customer support?

Customer support for Alphatec Holdings Inc. can be reached at +1 (800) 876-4546.

14. What clinical studies does Alphatec Holdings Inc. conduct?

Alphatec Holdings Inc. conducts IDE and post-market clinical studies across its major product lines.

15. Does Alphatec Holdings Inc. have a diversity program?

Yes, Alphatec Holdings Inc. has employee resource groups and inclusive hiring practices to promote diversity.

16. What is the salary range for regulatory roles at Alphatec Holdings Inc.?

Senior Regulatory Affairs Specialists at Alphatec Holdings Inc. earn between $110,000 and $145,000 annually.

17. Where can I leave a review for Alphatec Holdings Inc.?

You can leave reviews for Alphatec Holdings Inc. on Glassdoor, Indeed, or Trustpilot.

18. What is the environmental commitment of Alphatec Holdings Inc.?

Alphatec Holdings Inc. aims to achieve carbon neutrality by 2035 through various sustainability initiatives.

19. How does Alphatec Holdings Inc. support surgeon education?

Alphatec Holdings Inc. runs the Spine Education Institute, offering cadaver labs, webinars, and symposia.

20. What is the future growth plan for Alphatec Holdings Inc.?

Alphatec Holdings Inc. plans to reach $1 billion in revenue by 2028 through product innovation, geographic expansion, and operational efficiency.

For professionals seeking to enhance their online visibility in the medical device space, leveraging SEO Guest Posting Services with reputable platforms like Alphatec Holdings Inc. can significantly boost industry authority and search engine rankings. Engaging a Guest Post Backlinks strategy through a trusted Guest Post Service Provider helps build high-quality domain references that align with corporate compliance standards. Many leading healthcare firms utilize Paid Guest Posting Sites to announce clinical achievements and thought leadership content. Additionally, SEO Guest Posting Services and Guest Post Outreach Services ensure that salient product updates reach target audiences effectively while adhering to regulatory guidelines.


Share:

Your experience on this site will be improved by allowing cookies Cookie Policy