Senior Regulatory Specialist

About this role

Not quite right? These jobs in Bengaluru match the same skills — apply to a few to improve your chances.

Senior Associate 1 - Canada

KPMG Global Services

In OfficeBengaluru

Apply

Senior/Lead DevOps Engineer

Ericsson

In OfficeBengaluru

Apply

Associate - Category Sourcing Manager

JPMorgan Chase

In OfficeBengaluru

Apply

Senior - Business Controls

KPMG Global Services

In OfficeBengaluru

Apply

Skills you'll use

What you'll do

• · 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 in accordance with local regulatory requirements.
• · Assess the regulatory impact of product, labelling, manufacturing, supplier, specification, and design changes and determine required regulatory actions.
• · Maintain product registrations and licenses throughout the product lifecycle, ensuring continued compliance with applicable regulations and market requirements.
• · Coordinate with regional regulatory teams, distributors, and in-country representatives to support regulatory submissions and market access activities.
• · Monitor regulatory commitments, submission timelines, approval status, and renewal requirements to ensure uninterrupted product availability.
• · Review technical documentation, product information, labelling, and other supporting records for completeness, accuracy, and regulatory compliance.
• · Support post-market regulatory activities, including field actions, vigilance-related submissions, product updates, and compliance requests as required.
• · Maintain regulatory records, databases, and document repositories in accordance with internal procedures and document control requirements.
• · Track changing regulatory requirements within assigned markets and assess the impact on existing products and planned product launches.

Who can apply

• · Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline.
• · Experience - 5 years- 7 years and relevant 3 years of experience in Regulatory Affairs within the medical device, healthcare, pharmaceutical, or life sciences industry.
• · Experience supporting product registrations, renewals, amendments, and lifecycle management activities across APAC markets; supporting NPI and sustaining engineering activities from a regulatory perspective; working with regulatory information management systems, PLM systems, document control systems, or equivalent tools is preferred.
• · 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 processes.
• · Strong understanding of global regulatory frameworks and quality management principles applicable to medical devices.
• · Ability to perform regulatory impact assessments and independently determine submission strategies for changes.
• · Strong analytical, problem-solving, organisational, and project management skills.
• · Excellent written and verbal communication skills with the ability to collaborate effectively across global teams.
• · Ability to manage multiple priorities with minimal supervision in a fast-paced environment.

About Stryker

Searching for “Stryker jobs” or “jobs at Stryker”? You’re in the right place.