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Why join Stryker?
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Job description
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