Senior Regulatory Affairs Specialist (Hybrid)
About The Position
Stryker is hiring a Senior Regulatory Affairs Specialist for its Instruments/Neurosurgical division. This hybrid position is based in Portage, Michigan, with onsite work two to three days per week. The role works across functions to develop regulatory strategies, prepare submissions, maintain product registrations, and interpret evolving global regulatory requirements. It provides exposure to regulatory authorities, market access activities, product changes, audits, and post-market compliance. The specialist develops regulatory strategies and submission plans; prepares and submits regulatory documentation; evaluates product and manufacturing changes; supports post-market regulatory compliance; reviews advertising, promotional materials, labeling, and instructions for use; monitors regulatory intelligence; and partners with internal stakeholders to integrate regulatory requirements throughout product development and the product lifecycle. The role also supports inspections and audits, develops regulatory procedures and standard operating procedures, and trains stakeholders on changing requirements. Travel is 10%.
Requirements
- Bachelor’s degree in Engineering, Science, Life Sciences, or a related discipline.
- Minimum 2 years of experience in Regulatory Affairs or a related regulatory discipline within a regulated industry.
- Experience preparing, coordinating, or executing regulatory submissions and related documentation.
- Experience interpreting and applying regulatory requirements to product development, commercialization, or post-market activities.
Nice To Haves
- Master's degree in Regulatory Science or Regulatory Affairs Certification (RAC).
- Experience in the medical device industry.
- Experience supporting product registrations, regulatory submissions, product changes, or post-market regulatory activities across multiple markets.
- Experience interacting with regulatory authorities or supporting regulatory inspections and audits.
Responsibilities
- Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations.
- Prepare and submit regulatory documentation, including product registrations, annual licenses, listings, supplemental dossiers, and notifiable changes to applicable regulatory authorities.
- Evaluate product and manufacturing changes for regulatory impact and recommend submission, approval, and compliance requirements throughout the product lifecycle.
- Support post-market regulatory compliance, including safety reporting, product recalls, post-market commitments, required reports, and communications with regulatory authorities.
- Review advertising, promotional materials, product labeling, and instructions for use for alignment with applicable regulatory requirements.
- Monitor regulatory intelligence and assess emerging requirements, risks, and market access considerations to inform local, regional, and global regulatory strategies.
- Partner with Product Development, Quality, Marketing, and other stakeholders to integrate regulatory requirements into product development, commercialization, and lifecycle activities.
- Support regulatory inspections and audits, develop regulatory procedures and standard operating procedures, and train stakeholders on new or changing regulatory requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
