Regulatory Affairs Specialist

Cochlear

Not specified
Regulatory affairs
Medical device regulations
International submissions
Cochlear is seeking a Regulatory Affairs Specialist to support regulatory submissions and approvals for its medical devices across APAC, LATAM, and EMEA markets. The ideal candidate should possess a relevant degree, at least three years of experience in regulatory affairs or product development, and strong organizational and communication skills

Job Summary

  • The Regulatory Affairs Specialist provides regulatory support across the lifecycle of Cochlear products, focusing on submissions and approvals in APAC, LATAM and EMEA markets.
  • The role contributes regional requirements to global planning, provides regulatory guidance, and manages region‑specific documentation for submissions, tenders and legalization.
  • Employees enjoy working for Cochlear due to the opportunity to make a difference to people’s lives.

Matching Summary

Match Score: 85

Cochlear is seeking a Regulatory Affairs Specialist to support regulatory submissions and approvals for its medical devices across APAC, LATAM, and EMEA markets. The ideal candidate should possess a relevant degree, at least three years of experience in regulatory affairs or product development, and strong organizational and communication skills.

Skills & Requirements

Must-have

  • regulatory affairs
  • medical device regulations
  • international submissions
  • documentation management
  • cross-functional collaboration

Nice-to-have

  • continuous improvement
  • problem-solving abilities
  • attention to detail
  • adaptability to change

Key Requirements

  • Bachelor's degree in biomedical engineering, engineering, science, or related discipline
  • 3+ years experience in product development, quality, or regulatory affairs
  • Working knowledge of global medical device regulatory requirements
  • Proficiency in Microsoft Office

Work Rights

Not specified

Tailored Resume

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