Senior Regulatory Specialist

Stryker Corporation; India; On-site; Confidential; Full time

Job summary

Stryker Corporation is seeking a Regulatory Affairs professional to lead APAC regulatory support for NPI and sustaining activities. You will prepare and submit regulatory dossiers, assess impact of product changes, and maintain registrations across Hong Kong, Singapore, Macau, and Taiwan.

The role requires collaboration with QA, R&D, and regional teams to ensure compliant market access. The ideal candidate has 5–7 years in regulatory affairs for medical devices, strong knowledge of APAC regs,

Qualifications

• Bachelor's or master's degree in Engineering, Biomedical Engineering, Life Sciences, Pharmacy, Regulatory Affairs, or related discipline.
• 5–7 years regulatory experience in medical devices, healthcare, or life sciences.
• Experience supporting APAC product registrations, renewals, amendments, and lifecycle management.
• Knowledge of regulatory requirements for Hong Kong, Singapore, Macau, Taiwan, or other international medical device markets.
• Familiarity with design control, change control, and product lifecycle processes.
• Strong analytical and project management skills; excellent communication.

Responsibilities

• Lead regulatory support for NPI and sustaining activities in designated APAC markets.
• Prepare, compile, review, and submit regulatory dossiers, registrations, renewals, and amendments.
• Assess regulatory impact of product changes and determine required actions.
• Maintain registrations and licenses throughout product lifecycle.
• Coordinate with regional regulatory teams, distributors, and in-country representatives.
• Monitor submission timelines, approval status, and renewals for uninterrupted availability.
• Review technical documentation, labeling, and records for compliance.
• Support post-market regulatory activities including vigilance submissions and field actions.
• Maintain regulatory records and document repositories.
• Track changing regulatory requirements and assess impact on products and launches.
• Collaborate with QA, R&D, Product Engineering, Operations, Marketing, and Supply Chain.
• Independently manage multiple projects and priorities with high-quality outputs.

Skills

Regulatory Affairs

APAC Regulations

NPI Support

Documentation Management

Cross-functional Collaboration

Regulatory Submissions

Education

Regulatory Affairs degree

Biomedical/Engineering degree

Tools

PLM systems

Document control

Job description

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% Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.