Sr. Manager, ASEAN Lead
On-site · Singapore, Singapore or Kuala Selangor, Selangor, Malaysia
Job Summary
Senior leadership role to drive regional Regulatory Affairs strategy across ASEAN for DePuy Synthes, partnering with Commercial Quality, Quality, Supply Chain, and R&D to ensure regulatory compliance, market access, and lifecycle management across diverse ASEAN markets. Lead registrations, renewals, variations, and lifecycle activities; serve as primary regional RA partner to Commercial, Quality, Supply Chain, and R&D to support launches and issue management; ensure compliance with ASEAN, MOH/HSA/NMPA/PMDA equivalents; oversee regulatory intelligence, risk assessment, and governance; mentor regional RA professionals and represent Asia in global regulatory forums and audits. Requires Bachelor’s degree (required), 10-12 years in regulatory/quality affairs in medical devices/orthopedics, strong ASEAN regulatory knowledge, English fluency, and willingness to travel. Preferred RAC or equivalent regulatory certification; Travel: moderate international travel within Asia; Location flexibility includes Singapore or Selangor, Malaysia.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related discipline (required)
- 10-12 years of progressive experience in Regulatory Affairs and/or Quality Affairs within medical devices, orthopedics, or a regulated healthcare industry
- Demonstrated experience leading regional or multi-country regulatory activities in Asia
- Strong knowledge of ASEAN regulatory frameworks and global regulatory standards
- Proven ability to lead and develop teams and influence without authority in a matrixed organization
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