Senior Specialist, Regulatory Affairs

Stryker - Portage, MI

Hiring: Senior Specialist, Regulatory Affairs Company: Stryker Location: Portage, MI Job Posted Time: 2026-09-10 11:22:45 Employment Type: Hybrid About the job Experience: •2 years of experience in regulatory affairs within the medical device, biotechnology, pharmaceutical, healthcare industry, or other regulated industries. •Minimum 2 years of experience in regulatory affairs within the medical device, biotechnology, pharmaceutical, healthcare industry, or other regulated industries. Required Skills: •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. Qualifications: •Bachelor's degree required. Preferred in Regulatory Affairs, Engineering, Life Sciences, Biological Sciences, or a related field. •Master's degree in Regulatory Affairs, Engineering, Life Sciences, or a related discipline. •Posted Date: 09/01/2026 This role will be posted for a minimum of 3 days. Compensation: •$83,300 - $138,800 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!