Manager Regulatory Operations

Cochlear

Kuala Lumpur, Malaysia
**
Product registrations
Regulatory intelligence
Product labelling development
** Cochlear is seeking a Manager of Regulatory Operations to lead a team in Kuala Lumpur, Malaysia, focused on product registrations, regulatory compliance, and team development within the medical device industry. The role requires extensive experience in regulatory affairs, particularly in medical devices, and offers opportunities for team leadership and cross-functional collaboration. **

Job Summary

  • The Manager - Regulatory Operations leads a team of specialists responsible for supporting product registrations, information management, regulatory intelligence, product requirements, labelling development and maintenance across Cochlear’s acoustics and cochlear implant portfolios.
  • The role provides guidance across the pre-market and post-market phases, ensuring documentation is “submission ready” and that product and process changes meet global regulatory requirements.
  • In this role, the Manager will develop a strong Regulatory Operations team within the Cochlear Malaysia site, working closely with teams across multiple global sites to influence how Cochlear delivers regulatory support across international markets.

Matching Summary

Match Score: 75

** Cochlear is seeking a Manager of Regulatory Operations to lead a team in Kuala Lumpur, Malaysia, focused on product registrations, regulatory compliance, and team development within the medical device industry. The role requires extensive experience in regulatory affairs, particularly in medical devices, and offers opportunities for team leadership and cross-functional collaboration. **

Skills & Requirements

Must-have

  • product registrations
  • regulatory intelligence
  • product labelling development
  • global regulatory requirements
  • cross-functional regulatory leadership

Nice-to-have

  • continuous improvement of regulatory systems
  • develop future leaders
  • influence international markets

Key Requirements

  • Bachelor’s degree or equivalent experience
  • 5-7+ years regulatory affairs experience
  • 5-7+ years medical device product/software development
  • Proven track record managing high-performing teams
  • Strong understanding of global regulations
  • Regulatory Affairs Certification (RAC) desired

Work Rights

Not specified

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