Senior Specialist, Regulatory Affairs

Stryker • Portage, MI

23h • Hybrid

About The Position

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

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

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