Regional Regulatory Affairs Manager

transmedic group

Malaysia, Kuala Lumpur

8-10 Years

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Posted 4 days ago
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Job Description

Key Responsibilities 2. Team Leadership3. Regulatory Intelligence4. Quality & Compliance5. Process Improvement6. Cross-Functional CollaborationRequirements

Regulatory Strategy & Operations
Lead regulatory activities across assigned countries for all medical device portfolios.
Develop regulatory strategies to support new product launches, product lifecycle management and market expansion.
Ensure timely submission of product registrations, renewals, amendments, notifications and regulatory maintenance activities.
Monitor registration timelines and proactively manage risks affecting commercial launch plans.
Maintain regulatory compliance with local medical device regulations and applicable standards.
Lead, coach, and develop the Regional Regulatory Affairs team.
Allocate resources, prioritise workloads, and set performance objectives across countries and business units.
Foster a high-performing, collaborative, and customer-focused team culture.
Monitor regulatory changes, assess business impact and risks, and lead the implementation of new regulatory requirements across the region.
Ensure regulatory documentation complies with applicable regulations and the Company's Quality Management System (GDPMD).
Support internal, external, and principal audits, CAPA investigations, change control, and regulatory compliance activities.
Maintain regulatory inspection readiness across the region.
Drive continuous improvement by enhancing regulatory processes, systems, reporting, SOPs, work instructions, and best practices.
Monitor key performance indicators and prepare management reports.
Work closely with Commercial, Marketing, Supply Chain, Customer Service and Quality teams to support business objectives.
Provide regulatory assessments for new business opportunities, acquisitions and portfolio expansions.
Support product launches by ensuring regulatory readiness and alignment with commercial timelines.
Bachelor's degree in Life Sciences, Pharmacy, Biomedical Science, Engineering or related discipline.
Minimum 8 years of regulatory affairs experience in the medical device industry.
At least 3 years of people management experience leading regional or multi-country teams.
Strong knowledge of ASEAN medical device regulations. Experience with Hong Kong and other Asia Pacific markets is an advantage.
Experience working with Class A-D medical devices across multiple therapeutic areas is preferred.
Familiarity with GDPMD and quality management systems.
Proficiency in Microsoft Office and regulatory information management systems.
Strong leadership and people development skills.
Excellent stakeholder management and influencing abilities.
Strong project management and organisational skills.
Ability to manage multiple priorities in a fast-paced environment.
Analytical and problem-solving mindset.
Excellent written and verbal communication skills.
High attention to detail while maintaining strategic oversight.