Work Flexibility: Hybrid

As a Senior Manager, Regulatory Affairs on Stryker's Joint Replacement market access team, you will provide leadership and guidance to integrate regulatory considerations into global product continuity and exit strategy. 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.   

To learn more about Stryker's Joint Replacement portfolio click here: Joint replacement | Stryker

You will need to live within commuting distance to our Mahwah, New Jersey office. You will need to be in the office 2 days a week.

What you will do

Provide guidance to integrate regulatory considerations into global product maintenance and exit strategies.

Evaluate changing regulations, their implications on renewal and post-approval strategies, and develop solutions for market access challenges.

Collaborate effectively cross-functionally and provide strategic input and technical guidance on global regulatory requirements.

Ensure that submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission.

Lead interactions with regulatory authorities, manage complex negotiations, and participate in advocacy initiatives on a global scale.

Represent regulatory processes during internal and external audits.

Establish KPIs, manage regulatory metrics, and optimize resource allocation for efficient project execution.

Recruit, develop, and retain a high-performing team, fostering engagement and addressing performance issues effectively.

What you need

Required Qualifications:

Bachelor's degree in science, engineering or related field

Minimum of 10 years’ experience

Demonstrated leadership, management, and process improvement skills

Demonstrated ability to develop direct reports and encourage healthy team dynamic

Preferred Qualifications:

Minimum of 12 years’ experience

Master's Degree or equivalent

RAC desired

Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements

Demonstrate technical knowledge of medical device product lines

Demonstrated written, verbal, listening, communication, and team-building skills

Demonstrated ability to collaborate effectively with and lead cross-functional teams

Demonstrated ability to effectively prioritize and manage multiple project workloads

Demonstrated experience with trending and analysis reporting

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.