Staff Engineer Regulatory Affairs (APAC)

About the role

Stryker is hiring a Staff Engineer Regulatory Affairs in Bengaluru, working in a hybrid setup. You will lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets, including Hong Kong, Singapore, Macau and Taiwan.

Key responsibilities

• Prepare, compile, review and submit regulatory dossiers, registrations, renewals, amendments and notifications in line with local requirements.
• Maintain product registrations and licenses throughout the product lifecycle and monitor submission timelines and approval status.
• Assess the regulatory impact of product, labelling, manufacturing, supplier, specification and design changes and determine required actions.
• Review technical documentation, labelling and supporting records for completeness and compliance.
• Support post-market activities such as field actions, vigilance submissions, product updates and compliance requests.
• Coordinate with regional regulatory teams, distributors and in-country representatives, and support audits, inspections and compliance assessments.
• Track changing regulatory requirements and work with Quality, R&D, Product Engineering, Operations, Marketing and Supply Chain teams.
• Manage multiple projects independently and identify process improvements across APAC regulatory activities.

Required profile

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs or a related discipline.
• 5 to 7 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.
• Preferred: experience supporting NPI and sustaining engineering from a regulatory perspective, and familiarity with regulatory information management, PLM and document control systems.

Required skills

• Working knowledge of regulatory requirements for Hong Kong, Singapore, Macau, Taiwan or other international medical device markets.
• Familiarity with technical documentation, design control, change control and product lifecycle management.
• Ability to perform regulatory impact assessments and determine submission strategies for changes.
• Strong analytical, problem-solving, organisational and project management skills, and excellent written and verbal communication.
• Preferred: knowledge of ASEAN medical device regulations, UDI and product registration databases, and experience with distributors and local country representatives.