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Stryker is a global leader in medical technologies, committed to improving healthcare outcomes. With innovations in MedSurg, Neurotechnology, and Orthopaedics, Stryker impacts over 150 million patients annually. The company fosters an award-winning culture, offering growth opportunities, wellness programs, and performance rewards.
Job Details
- Job Title: Regulatory Affairs Specialist
- Location: Gurugram, India (Hybrid)
- Job ID: R545275
- Employment Type: Full-time
- Travel: 10%
- Relocation: No
Detailed Job Description
Key Responsibilities:
✔ Regulatory Compliance & Submissions:
- Assess post-launch device changes for regulatory impact.
- Prepare submissions for FDA, Notified Bodies, and global regulatory agencies.
- Ensure compliance with legal frameworks and regulatory requirements.
✔ Product Lifecycle Management:
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- Support new product development for domestic & international markets.
- Evaluate regulatory implications of product modifications.
- Contribute to regulatory strategy updates based on changing guidelines.
✔ Project Management & Documentation:
- Assist in SOP development and review.
- Manage regulatory documentation and approvals.
- Collaborate with cross-functional teams (R&D, QA, Legal).
✔ Regulatory Research & Strategy:
- Investigate regulatory history of medical devices.
- Determine approval requirements for new and modified products.
Eligibility & Qualifications
Required:
- Bachelor’s/Master’s degree in Regulatory Affairs, Engineering, or related field.
- 3-5 years of experience in Regulatory Affairs (RAQA) within an R&D environment.
- Knowledge of FDA, CE Marking, and global regulatory processes.
Preferred:
- Experience in post-market surveillance & change management.
- RAC Certification (Regulatory Affairs Certification).
- Strong project management & technical writing skills.
Benefits & Culture at Stryker
✅ Competitive Salary & Bonuses
✅ Healthcare & Insurance Benefits
✅ Retirement & Wellness Programs
✅ Performance Awards & Career Growth
✅ Hybrid Work Flexibility
Stryker promotes diversity, innovation, and employee well-being—ranked among Fortune’s Best Workplaces in Healthcare.
How to Apply
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