Manager, Regulatory Affairs

Stryker • Portage, IL

2d • $126,500 - $273,900 • Hybrid

About The Position

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 cross‑functional 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 high‑performing 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.

Requirements

• Bachelor of Science in Science or Engineering
• Minimum of 8+ years’ experience in an FDA-regulated industry with demonstrated experience in leading 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.

Nice To Haves

• Master's 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.

Responsibilities

• Develop and execute global, regional, and multi‑country 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 cross‑functional 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 non‑government organizations throughout development, approval, and post‑market phases.
• Oversee regulatory submissions, inspections, and agency interactions, including eCTD management, advisory committees, and pre‑approval, GCP, and clinical investigator inspections.
• Monitor and adapt regulatory strategies in response to changing regulations, ensuring compliance and optimizing pre‑approval and post‑approval 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 high‑performing regulatory team, including talent acquisition, performance management, goal setting, budgeting, forecasting, metrics, and stakeholder engagement.

Benefits

• Innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager