Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs – Joint Replacement Division
Location: Hybrid – Mahwah, NJ

As the Senior Manager, Regulatory Affairs , you will provide leadership and coordination of the Joint Replacement divisions’ global regulatory strategies, submission preparation and approvals for new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones and cultures to achieve market access in alignment with global regulatory requirements.

What You Will Do

• Lead development and execution of global regulatory strategies for new product launches, ensuring alignment with business objectives.

• Manage regulatory submissions for market access, including 510(k), PMA, and international approvals, achieving timely clearances.

• Oversee Patient-Specific Solutions regulatory processes to secure custom device approvals through compassionate use pathways.

• Direct interactions with health authorities (e.g., FDA, EU Notified Bodies) and guide internal teams through regulatory communications.

• Monitor and implement new regulatory requirements, providing actionable plans to maintain compliance.

• Ensure accuracy and completeness of submissions, labeling, and marketing materials to meet regulatory standards.

• Recruit, develop, and lead a high-performing Regulatory Affairs team, setting clear KPIs and performance objectives.

• Prepare and manage departmental budgets and forecasts, ensuring resource allocation aligns with strategic priorities.

What You Will Need

Required Qualifications

• Bachelor’s degree required. Preferred to be in Engineering, Science, or related field.

• Minimum 10 years of experience in an FDA-regulated industry.

• Minimum 5 years of experience in a supervisory or people leadership role.

• Experience in the medical device industry required.

Preferred Qualifications

• Master’s degree or Regulatory Affairs Certification (RAC).

• Experience with 510(k) and PMA submissions.

• Proven ability to lead geographically dispersed, international teams

$155,500 - $264,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Posted date: 12.3.25