If you are looking to advance your career in Regulatory Affairs (RA) within the medical devices or pharmaceutical industry, this opportunity at Stryker could be a strong fit. The role of Senior Regulatory Affairs Specialist in Gurugram offers exposure to global regulatory frameworks including FDA, EU MDR, and emerging markets, making it ideal for professionals aiming to build expertise in regulatory submissions and compliance.
This Regulatory Affairs job in India is designed for candidates with 3–6 years of experience who want to work in a cross-functional, global environment and contribute to regulatory strategy, documentation, and submissions.
Job Overview
- Position: Senior Regulatory Affairs Specialist
- Company: Stryker
- Location: Gurugram, India
- Job Type: Full-time (Hybrid)
- Experience: 3–6 years
- Industry: Medical Devices / Pharma
- Travel Requirement: ~10%
Key Responsibilities
As a Senior RA Specialist, you will play a critical role in ensuring regulatory compliance and supporting global submissions:
- Support regulatory strategy execution for global and regional submissions
- Prepare and compile regulatory dossiers such as FDA 510(k), EU MDR Technical Files
- Assist in identifying regulatory pathways for product lifecycle changes
- Maintain and update Regulatory Information Management (RIM) systems
- Coordinate cross-functional inputs from R&D, Quality, Clinical, and Marketing teams
- Ensure submission documents meet accuracy, completeness, and compliance standards
- Support eCTD and non-eCTD publishing activities
- Track submission timelines and ensure on-time regulatory deliverables
- Assist in responding to regulatory authority queries
- Maintain audit-ready regulatory documentation and technical files
- Contribute to SOPs, regulatory processes, and internal audits
- Monitor global regulatory changes (FDA, EU MDR, CDSCO, etc.)
Required Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or related field
- Advanced degree preferred (M.Pharm, MSc, etc.)
- 3–6 years experience in Regulatory Affairs / Regulatory Operations
- Experience with regulatory submissions and documentation
- Exposure to global regulations: FDA, EU MDR, TGA, NMPA, PMDA, CDSCO
Key Skills & Competencies
- Strong understanding of regulatory submission processes
- Knowledge of global regulatory frameworks and compliance standards
- High attention to detail in managing large documentation sets
- Strong project coordination and organizational skills
- Ability to collaborate across cross-functional teams
- Excellent written and verbal communication
- Process-driven mindset with focus on standardization and efficiency
- Ability to work independently in a fast-paced global environment
Benefits of Working at Stryker
- Opportunity to work on global regulatory submissions (FDA, EU MDR)
- Exposure to international regulatory frameworks
- Hybrid work flexibility
- Career growth in medical devices regulatory affairs
- Collaborative and innovation-driven work environment
How to Apply
