• Senior Manager, Regulatory Affairs

    Stryker (Mahwah, NJ)


    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

     

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

     

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.