Job Summary

Global MNC Tech is seeking an experienced and highly motivated Regulatory Affairs Manager – Remote MedTech (SEA) to lead and manage regulatory activities across Southeast Asia (SEA) markets. This role is critical in ensuring that all medical technology products comply with local and international regulatory requirements, enabling timely product registrations, renewals, and market expansions.

As a key strategic partner to R&D, Quality, Clinical, and Commercial teams, the Regulatory Affairs Manager will drive regulatory strategy, manage submissions, and act as the primary regulatory liaison with health authorities across the SEA region. This is a fully remote role offering the opportunity to work with a global MedTech portfolio while influencing regulatory success in high-growth emerging markets.

Key Responsibilities

• Develop and implement regulatory strategies for medical devices and digital health products in SEA markets.

• Lead end-to-end regulatory submissions including product registrations, renewals, variations, and amendments.

• Ensure compliance with regional regulatory frameworks (e.g., ASEAN Medical Device Directive - AMDD).

• Serve as the primary point of contact with regulatory authorities and notified bodies.

• Prepare, review, and maintain technical documentation, dossiers, and regulatory files.

• Monitor regulatory intelligence and assess impact of changing regulations on existing and pipeline products.

• Collaborate cross-functionally with Quality Assurance, R&D, Clinical, Manufacturing, and Commercial teams.

• Support audits, inspections, and regulatory inquiries.

• Manage external regulatory consultants and local agents in SEA countries.

• Provide regulatory guidance for new product development and market entry strategies.

Required Skills and Qualifications

• Bachelors degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or related field (Masters preferred).

• Strong understanding of global medical device regulations (FDA, EU MDR, ASEAN, ISO 13485).

• Excellent regulatory writing and documentation skills.

• Proven ability to manage multiple submissions across different markets.

• Strong analytical, problem-solving, and risk assessment skills.

• Excellent communication and stakeholder management abilities.

• Proficiency in regulatory information management systems (RIMS).

• High attention to detail with strong organizational skills.

Experience

• 6+ years of experience in Regulatory Affairs within the MedTech or medical device industry.

• Demonstrated experience handling regulatory submissions in SEA markets (Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam).

• Experience working in a multinational or global regulatory environment.

• Prior experience managing regulatory strategy for Class II and III medical devices preferred.

Working Hours

• Full-time, remote position.

• Flexible working hours aligned with SEA business operations.

• Occasional virtual meetings across global time zones.

Knowledge, Skills and Abilities

• In-depth knowledge of ASEAN regulatory frameworks and international medical device standards.

• Ability to interpret complex regulations and translate them into actionable business strategies.

• Strong project management and planning skills.

• High level of professionalism and ethical judgment.

• Ability to work independently in a remote environment.

• Capability to manage regulatory risk and compliance in fast-paced product environments.

• Strong cross-cultural communication skills.

Benefits

• Competitive salary package with performance-based incentives.

• Fully remote work model with global exposure.

• Health insurance and wellness programs.

• Professional development and regulatory certification support.

• Access to global training platforms and leadership programs.

• Paid time off, holidays, and flexible leave policies.

Why Join Global MNC Tech?

At Global MNC Tech, you will be part of a forward-thinking organization at the forefront of medical technology innovation. We empower our professionals to take ownership, drive impact, and shape the future of healthcare. This role offers the opportunity to influence regulatory strategy across high-growth SEA markets while working in a flexible and globally connected environment.

You will collaborate with international experts, work on cutting-edge MedTech solutions, and contribute directly to improving patient outcomes across diverse healthcare systems.

How to Apply

Interested candidates are invited to submit their updated CV along with a brief cover letter outlining their regulatory experience in MedTech and SEA markets.

Please apply through our official careers portal or send your application to the Global MNC Tech recruitment team. Shortlisted candidates will be contacted for a virtual interview process.