Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs page is loaded## Senior Manager, Regulatory Affairs locations:
Mahwah, New Jersey time type:
Full time posted on:
Posted Todayjob requisition :
R554641

Work Flexibility:
Hybrid
** Senior Manager, Regulatory Affairs – Joint Replacement Division*
* *
* Location:

** Hybrid – Mahwah, NJAs 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

Travel Percentage : 10%
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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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