Job Summary

Global MNC Tech is seeking an experienced Regulatory Affairs Manager to join our dynamic MedTech team in the APAC region. This fully remote role focuses on ensuring our innovative medical devices comply with regulatory requirements across multiple countries in APAC. You will serve as a key liaison with regulatory authorities, provide strategic guidance on product approvals, and support market expansion while maintaining the highest standards of compliance.

Key Responsibilities

• Lead regulatory strategy development for medical device product submissions in the APAC region.

• Prepare, review, and submit regulatory documentation to relevant authorities, including product registrations, amendments, and renewals.

• Monitor and interpret changes in regulatory requirements, ensuring timely implementation across the organization.

• Collaborate closely with R&D, Quality, Clinical, and Marketing teams to ensure regulatory compliance from product development to commercialization.

• Provide expert guidance on labeling, promotional materials, and product lifecycle management from a regulatory perspective.

• Serve as the primary contact with regulatory agencies, ensuring smooth and effective communications.

• Develop and deliver regulatory training programs to internal stakeholders.

• Support audits and inspections by regulatory authorities and respond to inquiries effectively.

Required Skills and Qualifications

• Bachelors degree in Life Sciences, Pharmacy, Engineering, or a related field. Advanced degrees preferred.

• Deep understanding of regulatory frameworks for medical devices in APAC, including TGA (Australia), PMDA (Japan), SFDA (China), and ASEAN countries.

• Strong knowledge of ISO 13485, MDR, IVDR, and other relevant quality and compliance standards.

• Proven ability to manage complex regulatory projects with multiple stakeholders.

• Excellent written and verbal communication skills in English; additional APAC regional languages are a plus.

• High level of attention to detail and ability to meet strict deadlines.

Experience

• Minimum 5–8 years of experience in regulatory affairs within the MedTech or medical device sector.

• Prior experience with regulatory submissions and approvals in multiple APAC countries.

• Experience working in global or cross-functional teams is highly preferred.

Working Hours

• Fully remote position with flexible working hours, aligned to APAC time zones.

• Occasional participation in global meetings may require coordination across different time zones.

Knowledge, Skills, and Abilities

• Strong analytical and problem-solving skills with the ability to interpret complex regulations.

• Strategic thinking with a proactive approach to compliance challenges.

• Ability to prioritize multiple projects and manage deadlines independently.

• Exceptional interpersonal skills to work effectively with cross-functional teams and external stakeholders.

• Comfortable using digital tools for document management, submissions, and reporting.

Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and wellness coverage.

• Remote work flexibility with home office support.

• Professional development and continuous learning opportunities.

• Generous leave policy and work-life balance support.

• Opportunity to work with a globally recognized MedTech innovator.

Why Join Global MNC Tech

At Global MNC Tech, you will join a forward-thinking, inclusive, and innovative environment where your expertise directly impacts patient care and the advancement of medical technology in APAC. We invest in our employees, offering growth opportunities, meaningful work, and a culture that values collaboration and excellence.

How to Apply

Qualified candidates are invited to submit their resume and a cover letter detailing their relevant experience and motivation to join our team. Please apply through our careers portal or send applications to us with the subject line: Regulatory Affairs Manager – APAC.