Senior Manager, Regulatory Affairs

Stryker • Mahwah, NJ

2d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree required.
• 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.

Nice To Haves

• Preferred to be in Engineering, Science, or related field.
• Master’s degree or Regulatory Affairs Certification (RAC).
• Experience with 510(k) and PMA submissions.
• Proven ability to lead geographically dispersed, international teams

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees