Regulatory Affairs Specialist
Cochlear(1 month ago)
About this role
The Regulatory Affairs Specialist at Cochlear provides regulatory support across the product lifecycle with a focus on submissions and approvals for APAC, LATAM and EMEA markets. The role contributes regional requirements to global planning, manages region‑specific documentation and maintains accurate product and certification records. The specialist also supports engineering and manufacturing teams by assessing product and process changes for regulatory impact.
Required Skills
- Regulatory Submissions
- Documentation Management
- Labeling
- Compliance
- QMS
- Risk Management
- Requirements Management
- Verification
- Stakeholder Collaboration
- Microsoft Office
Qualifications
- Bachelor's Degree in Biomedical Engineering or Related
- RACS Certification
- Advanced Degree (Preferred)
About Cochlear
cochlear.comCochlear is a leader in hearing device implants that help to restore hearing and connect people to a world of sound. Start your hearing journey today!
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