Senior Regulatory Specialist

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-

Bachelors or Masters 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.