Senior Specialist, Regulatory Affairs

Stryker is hiring a Senior Specialist, Regulatory Affairs
. Join a team that supports regulatory initiatives across the product lifecycle, with a focus on sustaining and environmental regulatory activities to help ensure products remain compliant with applicable global regulatory requirements. This role partners with cross-functional teams to assess regulatory implications, support submission planning, and provide regulatory guidance that informs product and business decisions.

Strong preference will be given to candidates who reside within a commutable distance of Portage, Michigan and can work a hybrid schedule.

• Support development, review, and maintenance of regulatory procedures and documentation.

• Contribute to regulatory strategies and recommend updates based on evolving regulations, guidance, and industry standards.

• Assess and support compliance with global regulatory and environmental requirements, evaluating potential impacts of evolving regulations on products, processes, and business activities.

• Provide regulatory input for product development, lifecycle management, and change planning activities.

• Evaluate regulatory requirements and potential impacts for new products, product modifications, and business initiatives.

• Research and assess regulatory history, product classifications, and therapeutic or diagnostic landscapes to identify regulatory pathways and considerations.

• Identify potential regulatory risks, trade-related considerations, and approval challenges, and communicate findings to project teams.

• Define submission, registration, and approval requirements and support preparation of regulatory deliverables.

• Participate in risk-benefit assessments and compare regulatory outcomes against original product concepts to support future recommendations and regulatory planning.

• Bachelor's degree required. Preferred in Regulatory Affairs, Engineering, Life Sciences, Biological Sciences, or a related field.

• Minimum 2 years of experience in regulatory affairs within the medical device, biotechnology, pharmaceutical, healthcare industry, or other regulated industries.

• Experience assessing and supporting compliance with environmental regulations and reporting requirements.

• Experience supporting products throughout the full product lifecycle, including development, commercialization, and post-market activities.

• Regulatory Affairs Certification (RAC).

• Master's degree in Regulatory Affairs, Engineering, Life Sciences, or a related discipline.

• USN
  : $83,300 - $138,800 USD Annual
• US5
  : $87,500 - $145,700 USD Annual
• US10
  : $91,600 - $152,700 USD Annual
• US15
  : $95,800 - $159,600 USD Annual
• US20
  : $100,000 - $166,600 USD Annual
• US30
  : $108,300 - $180,400 USD Annual

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