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Hiring companyStryker
Verified today
Senior Regulatory Affairs Specialist, Product Environmental Compliance
Gurugram, Haryana, India Full-time Hybrid
About the role
Regulatory Affairs team at Stryker Global Technology Center drives product compliance across the lifecycle. The Senior Regulatory Affairs Specialist develops and executes regulatory strategies, prepares submissions, and liaises with authorities to ensure market access. Gurugram, India, hybrid work model with occasional travel (10%).
What you’ll do
- Assess regulatory intelligence and develop strategies
- Prepare and submit regulatory filings
- Interact with regulatory authorities and advisory committees
- Guide cross‑functional teams on compliance requirements
- Monitor regulatory changes and update strategies
- Develop SOPs and train stakeholders
- Evaluate product classifications and jurisdiction
- Support clinical and non‑clinical data alignment
What you’ll bring
- BS or MS degree in relevant field
- 2+ years regulatory experience
- 5-7 years total experience
Skills
Regulatory strategySubmission preparationCross‑functional collaborationSOP developmentStakeholder trainingRegulatory intelligenceCompliance monitoringProject management
Education
BS in Engineering, Science, or related; MS in Regulatory Science