Director, Regulatory Affairs

Centinel Spine, LLC • West Chester, PA

2d • Onsite

About The Position

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
VP of 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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees