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Stryker is a global leader in medical technologies, committed to improving healthcare outcomes. With a strong presence in MedSurg, Neurotechnology, and Orthopaedics, Stryker impacts over 150 million patients annually. The company fosters an award-winning workplace culture, offering competitive benefits, career growth, and innovation-driven projects.
Job Details
- Job Title: Regulatory Affairs Specialist
- Location: Gurugram, India (122001)
- Work Flexibility: Hybrid
- Job Type: Full Time
- Travel: 10%
- Relocation: No
- Req ID: R545273
Detailed Job Description
Key Responsibilities:
- Regulatory Compliance: Assess post-launch product changes to determine regulatory impact.
- Submissions & Approvals: Prepare and submit documentation to FDA, Notified Bodies, and other regulatory agencies.
- New Product Development: Contribute to regulatory strategy for domestic and international product releases.
- Change Management: Evaluate regulatory implications of modifications to existing products.
- SOP Development: Assist in creating and reviewing Standard Operating Procedures (SOPs).
- Project Management: Coordinate and execute regulatory tasks efficiently.
Skills & Competencies:
- Strong understanding of regulatory frameworks (FDA, EU MDR, etc.)
- Ability to analyze scientific and technical regulatory requirements
- Excellent project management and communication skills
Eligibility Criteria
Required Qualifications:
- Bachelor’s or Master’s degree in Regulatory Affairs, Engineering, or related field.
- 3-5 years of experience in Regulatory Affairs within an R&D environment.
Preferred Qualifications:
- Experience in post-market surveillance & change management.
- RAC (Regulatory Affairs Certification) is a plus.
Benefits & Perks
Stryker offers an exceptional total rewards package, including:
✅ Performance Bonuses
✅ Healthcare & Insurance Benefits
✅ Retirement & Wellness Programs
✅ Career Development Opportunities
✅ Work-Life Balance (Hybrid Work Model)
✅ Social & Recreational Activities
How to Apply
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