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%