Deskripsi Pekerjaan
Join People Profilers as a Regional Regulatory Affairs Manager (Medical Device) and lead regulatory compliance strategies for innovative medical solutions. This senior role requires you to navigate complex regulatory landscapes across the Asia-Pacific region, ensuring product registrations meet stringent health authority requirements. You'll collaborate with cross-functional teams to develop regulatory strategies, manage submissions, and maintain compliance with evolving regulations including FDA, EMA, and HSA standards. The position offers the opportunity to shape regulatory frameworks for cutting-edge medical devices while mentoring junior staff and representing the company at industry forums. With competitive compensation and a focus on professional growth, this role is ideal for a proactive leader passionate about advancing healthcare innovation through regulatory excellence.
Tanggung Jawab
- Develop and implement regional regulatory strategies for medical device portfolios
- Lead preparation and submission of regulatory documentation to health authorities (HSA, FDA, EMA)
- Monitor and interpret global regulatory changes impacting medical device markets
- Manage product registrations and maintain compliance documentation
- Coordinate with R&D, quality, and manufacturing teams for regulatory alignment
- Represent company at regulatory meetings and industry conferences
- Mentor junior regulatory affairs professionals
- Conduct risk assessments for regulatory pathways
Kualifikasi
- Bachelor's degree in Life Sciences, Engineering, or related field; Master's preferred
- 4-6 years of regulatory affairs experience in medical devices
- Proven track record with ASEAN and international regulatory submissions
- Strong knowledge of ISO 13485, FDA QSR, and EU MDR requirements
- Experience managing regulatory teams and cross-functional projects
- Excellent communication and stakeholder management skills
- RAC certification or equivalent regulatory qualification
- Proficiency in regulatory submission databases and tools