The Regulatory Affairs Specialist provides regulatory support across the lifecycle of Cochlear products, focusing on submissions and approvals in APAC, LATAM and EMEA markets
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
The Regulatory Affairs Specialist provides regulatory support across the lifecycle of Cochlear products, focusing on submissions and approvals in APAC, LATAM and EMEA markets.
Skills & Requirements
Must-have
product lifecycle regulatory support
APAC LATAM EMEA market submissions
regulatory guidance and documentation
regulatory information management
product and process change assessment
international standards compliance
Nice-to-have
opportunity to make a difference
continuous improvement mindset
workplace health and safety commitment
Key Requirements
Bachelor's degree in relevant discipline
3+ years experience in product development, quality, or regulatory affairs
Strong organizational and attention to detail skills
Excellent written and verbal communication skills
Ability to work collaboratively in cross-functional teams
Working knowledge of global medical device regulatory requirements