Senior Regulatory Specialist

Stryker Group; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Stryker Group in Bengaluru is seeking an experienced Regulatory Affairs professional to lead APAC regulatory support for NPI and sustaining activities across Hong Kong, Singapore, Macau and Taiwan. You will prepare dossiers, assess regulatory impact, and ensure ongoing product registrations and licenses throughout the lifecycle.

Collaborating with Quality, R&D, Product Engineering, Operations, Marketing, and Supply Chain, you will manage multiple projects, track timelines, and drive submissions

Qualifications

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• 5-7 years of regulatory affairs experience in medical devices, healthcare, pharma, or life sciences.
• Experience with APAC registrations, lifecycle management, and regulatory submissions.

Responsibilities

• Lead regulatory support for NPI and sustaining activities in APAC markets (Hong Kong, Singapore, Macau, Taiwan).
• Prepare, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications.
• Assess regulatory impact of product changes and determine required regulatory actions.
• Maintain registrations and licenses across the product lifecycle to ensure compliance.
• Coordinate with regional teams, distributors, and in-country reps for submissions and market access.
• Monitor submission timelines, approvals, and renewals to ensure product availability.
• Review technical documentation, labeling, and records for regulatory compliance.
• Support post-market activities, including vigilance submissions and product updates.
• Maintain regulatory records and document repositories per internal procedures.
• Track regulatory changes and assess impact on products and launches.
• Collaborate with Quality, R&D, Product Engineering, Operations, Marketing, and Supply Chain to obtain required docs.
• Independently manage multiple projects with minimal supervision and timely outputs.
• Identify opportunities for process improvements across APAC regulatory activities.
• Support audits, inspections, and regulatory assessments with documentation and SME input.
• Proactively communicate risks and market access impacts to stakeholders.

Skills

Regulatory affairs

APAC regulations

NPI regulatory support

Documentation control

Quality systems

Project management

Stakeholder collaboration

Regulatory submissions

Education

Bachelor's or Master's in Engineering or Life Sciences

Tools

PLM systems

Regulatory information management

Document control systems

Job description

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.