Manager Regulatory Operations

Cochlear

Malaysia
5-7+ years regulatory affairs experience
Submission preparation and lifecycle maintenance
Global medical device regulatory requirements
The Manager leads a team responsible for product registrations, regulatory intelligence, and labeling across global regions

Job Summary

  • The Manager leads a team responsible for product registrations, regulatory intelligence, and labeling across global regions.
  • This role ensures documentation is submission-ready and that product changes meet international regulatory standards.
  • Employees enjoy the opportunity to make a difference in people's lives by developing world-leading hearing devices.

Matching Summary

The Manager leads a team responsible for product registrations, regulatory intelligence, and labeling across global regions.

Skills & Requirements

Must-have

  • 5-7+ years regulatory affairs experience
  • Submission preparation and lifecycle maintenance
  • Global medical device regulatory requirements
  • Team leadership and development skills
  • Cross-functional stakeholder management

Nice-to-have

  • Strong decision-making under ambiguity
  • Continuous improvement culture promotion
  • Future leader development focus
  • WHS and injury management commitment

Key Requirements

  • Bachelor's degree in engineering, legal, scientific, or healthcare
  • 5-7+ years in medical device product or software development
  • Proven track record managing high-performing teams
  • Master's or doctorate (Desired)
  • Regulatory Affairs Certification RAC (Desired)

Work Rights

Not specified

Tailored Resume

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