Senior Regulatory Affairs Specialist

Stryker India Private Limited; Karnataka; Hybrid; INR 1,200,000 - 2,100,000; Full time

Job summary

Stryker India Private Limited is seeking a Senior Regulatory Specialist to lead regulatory activities for APAC markets, including Hong Kong, Singapore, Macau, and Taiwan. You will manage dossiers, registrations, and lifecycle activities with cross-functional teams.

The role requires 5–7 years in regulatory affairs, strong communication, and a hands-on ability to navigate global frameworks, with hybrid work arrangement in India.

Qualifications

• Bachelor’s or Master’s in Engineering, Life Sciences, Pharmacy or Regulatory Affairs.
• 5–7 years in Regulatory Affairs for medical devices or life sciences.
• Experience supporting APAC registrations, renewals and lifecycle management.
• Knowledge of Hong Kong, Singapore, Macau, Taiwan markets.
• Familiar with design control, change control and product lifecycle.
• Strong communication and cross-functional collaboration.

Responsibilities

• Lead regulatory support for NPI and sustaining activities in APAC.
• Prepare, compile, review, and submit regulatory dossiers and registrations.
• Assess regulatory impact of product changes and determine actions.
• Maintain product registrations and licenses through lifecycle.
• Coordinate with regional teams, distributors and in-country reps.
• Monitor submission timelines and renewal requirements.
• Support post-market regulatory activities and field actions.
• Assist audits, inspections, and compliance assessments.

Skills

Regulatory Affairs

APAC Regulation

Regulatory submissions

Project management

Stakeholder communication

Education

Bachelor's/Master’s in Engineering/Life Sciences

Tools

Regulatory databases

PLM systems

Document control systems

Job description

Senior Regulatory Specialist

Work Flexibility: Hybrid

What you will 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.
• Collaborate with Quality, R&D, Product Engineering, Operations, Marketing, and Supply Chain teams to obtain required documentation and support regulatory deliverables.
• Independently manage multiple projects and priorities while delivering high-quality regulatory outputs within established timelines.
• Identify opportunities for process improvements, standardization, and efficiency enhancement across APAC regulatory activities.
• Support internal and external audits, inspections, and compliance assessments by providing regulatory documentation and subject matter expertise.
• Proactively communicate project risks, regulatory concerns, and potential market access impacts to stakeholders and management.

What you will need

Required Skills

• 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.

Preferred Skills

• Knowledge of ASEAN medical device regulations and international regulatory requirements.
• Experience working with distributors, local country representatives, and external regulatory partners; global product portfolios and cross-regional regulatory initiatives.
• Familiarity with UDI, product registration databases, and post-market regulatory processes.

Travel Percentage: 10% Experience Level Senior Level