Lead Specialist, Regulatory Affairs
Stryker(7 months ago)
About this role
A Regulatory Affairs professional who supports development and execution of local, regional, and global regulatory strategies across the product lifecycle to ensure compliance and enable market access. The role provides regulatory intelligence and guidance to cross-functional teams, advises on submission/approval pathways, and interacts with regulatory authorities to support product approvals.
Required Skills
- Regulatory Strategy
- Regulatory Intelligence
- Submission Preparation
- Compliance
- Project Management
- Risk-Benefit
- Stakeholder Training
- Labeling
- Clinical Evaluation
- SOP Development
+2 more
Qualifications
- BS in Engineering, Science, or Related Degree
- MS in Regulatory Science
- RAC(s)
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