Manager, Regulatory Affairs

Stryker is hiring a Manager Regulatory Affairs for our Ortho Tech Orthopaedic Instruments (OI) business in Portage MI responsible for leading global regulatory strategies across the full product lifecycle ensuring alignment with enterprise objectives and evolving regulatory market and safety requirements. This leader partners closely with crossfunctional teams to enable compliant efficient product development and market access while proactively assessing risk navigating complex regulatory pathways and driving engagement with global regulatory authorities and external stakeholders. This position also oversees regulatory operations policy development and inspections and builds and develops a highperforming regulatory team to support business growth and patient impact.

Workplace Flexibility: Ideal candidates will be within commuting distance of Portage MI and able to work in a hybrid capacity. Remote consideration may be possible with the expectation of onsite travel at least once per month and as business needs require.

What you will do:

• Develop and execute global regional and multicountry regulatory strategies aligned with enterprise and product portfolio objectives considering evolving global societal economic and regulatory trends.
• Lead regulatory pathway planning across the product lifecycle including product design development market entry expansion and exit strategies.
• Provide strategic regulatory guidance to crossfunctional teams (R&D Quality Clinical Supply Chain Marketing and Commercial) to ensure compliant efficient product development and market access.
• Assess regulatory risks safety considerations and market access barriers including reimbursement and distribution requirements and drive solutions to mitigate potential obstacles.
• Lead complex negotiations and interactions with global regulatory authorities advocacy groups and government and nongovernment organizations throughout development approval and postmarket phases.
• Oversee regulatory submissions inspections and agency interactions including eCTD management advisory committees and preapproval GCP and clinical investigator inspections.
• Monitor and adapt regulatory strategies in response to changing regulations ensuring compliance and optimizing preapproval and postapproval approaches including accelerated pathways where applicable.
• Establish and maintain regulatory policies procedures SOPs and training programs to ensure organizational compliance and continuous improvement.
• Manage and develop a highperforming regulatory team including talent acquisition performance management goal setting budgeting forecasting metrics and stakeholder engagement.

What you need:

Required

• Bachelor of Science in Science or Engineering
• Minimum of 8 years experience in an FDA-regulated industry with demonstrated experience inleading regulatory pathway planning across the full product lifecycle (development through market entry expansion and exit).
• Minimum of 3 years of people leadership experience including recruiting talent development team performance management and demonstrated process improvement and operational management skills.
• Demonstrated technical expertise across medical device product lines with strong working knowledge and application of ISO FDA and global regulatory requirements.

Preferred

• Masters Degree or equivalent preferred
• RAC certification or related certification desired
• Demonstrated ability to prioritize and manage multiple projects simultaneously leveraging data trending and analysis to influence decisions and outcomes across the organization.

United States of America Pay Ranges:

• USN: $126500 - $210700 USD Annual
• US5: $132800 - $221200 USD Annual
• US10: $139200 - $231800 USD Annual
• US15: $145500 - $242300 USD Annual
• US20: $151800 - $252800 USD Annual
• US30: $164500 - $273900 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.