Director, Regulatory Affairs

Centinel Spine®, LLC is the leading global medical device company exclusively focused on addressing cervical and lumbar spinal disease with prodisc®, the most complete total disc replacement (TDR) technology platform in the world.

The Company’s prodisc® technology is the most studied and clinically proven TDR system across the globe, validated by over 540 published papers and more than 300,000 implantations. Centinel Spine’s prodisc® is the only TDR technology with multiple motion-preserving anatomic solutions, allowing the surgeon to Match-the-Disc™ to each patient’s anatomy for both cervical and lumbar total disc replacement.

About the opportunity:

If you are driven by the opportunity to shape global health standards, we want you. As our Director, Regulatory Affairs, you will be the strategic architect behind our global product compliance. Reporting directly to the Vice President, Clinical, Regulatory, and Quality Affairs, you will lead the charge in navigating FDA, MDR, and international landscapes—ensuring our life-changing technologies move seamlessly from development to the patients who need them. This position is 100% on-site in West Chester, PA.

Where you will make an impact:

Partner with the VP on global regulatory strategies that accelerate product approvals.
Serve as the company lead with FDA and international bodies, leading all formal meetings, submissions, and inspections.
Develop proactive regulatory plans that align with business growth and commercial launch objectives.
Direct the preparation and maintenance of high-stakes domestic and international filings, including 510(k)s, IDEs, PMAs, and Technical Files.
Ensure rigorous adherence to EUMDR, FDA QSR, ISO 13485, and country-specific standards across the entire product lifecycle.
Provide critical regulatory oversight for clinical trials, managing applications, protocols, and labeling for both new and post-market studies.
Review and approve design changes, test protocols, and manufacturing rework to ensure they meet stringent regulatory expectations.
Maintain a robust Quality Management System (QMS), overseeing internal/external audits, product recalls, and UDI reporting.
Review and advise on all marketing programs, publications, and press releases to ensure product claims are compliant and accurate.
Recruit, mentor, and develop a high-performing regulatory team, providing the guidance needed to navigate complex filing processes and testing requirements.

What you will bring:

Bachelor’s degree in engineering or science degree (or equivalent) required.

7–10+ years of experience in regulatory affairs within the medical device industry, with a demonstrated track record of successful regulatory submissions (Class II, Class III and agency interactions (FDA and EU), strongly preferred.
Strong leadership, communication, and coaching abilities.
Ability to collaborate cross-functionally and influence without authority.
Excellent problem solving, analytical, and decision-making skills.
Ability to manage multiple priorities in a fast-paced environment.

Where you will go:

This position is 100% on-site at our West Chester, PA Corporate office.

What we offer:

A competitive annual base salary with an annual bonus.
A comprehensive healthcare benefits program that includes medical, dental, vision, life insurance and disability coverage along with several voluntary benefit programs. .
A generous paid time off and company paid holiday programs.
This is an excellent opportunity to work for a growing, team-orientated company passionate about making a difference and improving patient lives.

Note: The above job description describes the general nature and level of work being performed by employees assigned to this position. It is not intended to be construed as an all-inclusive list of all responsibilities, duties and skills required of all employees assigned to this position. Duties, responsibilities and activities may change at any time with or without notice. Centinel Spine is proud to be an equal opportunity employer.

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Skills Self-Assessment

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Experience level with FDA, EUMDR, FDA QSR and ISO 13485.
Experience level with domestic and international filings, including 510(k)s, IDEs, PMAs, and Technical Files.

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