Stryker
Bengaluru, Karnataka, India Posted 5d ago
Stryker is seeking a Staff Engineer Regulatory Affairs to lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets. You will prepare, compile, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications.
Key Responsibilities
Lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets, including Hong Kong, Singapore, Macau, and Taiwan.
Prepare, compile, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications.
Assess the regulatory impact of product, labelling, manufacturing, supplier, specification, and design changes.
Maintain product registrations and licenses throughout the product lifecycle, ensuring continued compliance.
Coordinate with regional regulatory teams, distributors, and in-country representatives to support submissions.
Monitor regulatory commitments, submission timelines, approval status, and renewal requirements.
Review technical documentation, product information, labelling, and other supporting records for completeness and accuracy.
Support post-market regulatory activities, including field actions and vigilance-related submissions.
Requirements
Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or related discipline.
5-7 years of experience with at least 3 years of relevant experience in Regulatory Affairs within the medical device, healthcare, pharmaceutical, or life sciences industry.
Experience supporting product registrations, renewals, amendments, and lifecycle management across APAC markets.
Working knowledge of regulatory requirements for Hong Kong, Singapore, Macau, Taiwan, or other international markets.
Familiarity with technical documentation, design control, and change control.
Preferred Qualifications
Knowledge of ASEAN medical device regulations and international regulatory requirements.
Experience working with distributors, local country representatives, and external regulatory partners.
