Senior Manager, Regulatory Affairs
Listed on 2026-01-27
-
Management
Healthcare Management -
Healthcare
Healthcare Management, Healthcare Administration
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.
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.
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.
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
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