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Staff Regulatory Affairs Specialist (Hybrid)
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Full-time
- Stryker is seeking a Staff Regulatory Affairs Specialist to join our Instruments division located in Portage, MI. This is a hybrid position requiring two days per week in the office.
- As the Staff Regulatory Affairs Specialist, you will engage in technical and scientific regulatory activities to include project management, writing, coordination, and execution of regulatory documentation for new product development.
- Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
- Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
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