Senior Regulatory Specialist
Stryker · Bengaluru, India
RegulatoryFull-timeCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
What they're looking for
- Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, or Regulatory Affairs
- 5-7 years total experience with minimum 3 years in Regulatory Affairs for medical devices or life sciences
- Working knowledge of Hong Kong, Singapore, Macau, Taiwan, or other international medical device regulatory requirements
- Experience with product registrations, renewals, amendments, and lifecycle management in APAC markets
- Strong analytical and project management skills with ability to manage multiple priorities independently
- Proficiency with regulatory information systems, PLM systems, or document control systems
- Excellent written and verbal communication skills for cross-functional collaboration
What you'll be doing
- Lead regulatory support for new product introductions and sustaining activities across designated APAC markets
- Prepare, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications per local requirements
- Assess regulatory impact of product, labeling, manufacturing, and design changes to determine required actions
- Coordinate with regional teams, distributors, and in-country representatives to support regulatory submissions and market access
- Monitor regulatory commitments, timelines, and renewal requirements to maintain product availability and compliance
Privacy & handoff
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