The Senior Regulatory Affairs Specialist provides regulatory support across the full lifecycle of Cochlear products, guiding teams on global requirements
Job Summary
The Senior Regulatory Affairs Specialist provides regulatory support across the full lifecycle of Cochlear products, guiding teams on global requirements.
This role serves as a primary liaison between global regions and R&D teams to address inquiries and resolve issues while representing regional needs in corporate discussions.
Employees enjoy working at Cochlear because it offers the opportunity to make a difference to people's lives through world-leading medical devices.
Matching Summary
The Senior Regulatory Affairs Specialist provides regulatory support across the full lifecycle of Cochlear products, guiding teams on global requirements.
Skills & Requirements
Must-have
Bachelor's degree in engineering or science
3-5+ years regulatory affairs experience
Global medical device regulatory knowledge
Strong report writing and documentation skills
Ability to influence stakeholders in matrix environment
Nice-to-have
Master's or doctorate degree preferred
RAC certification
Experience with software development regulations
Proven ability to work in ambiguous conditions
Key Requirements
Bachelor's degree required
3-5+ years experience in product development or regulatory affairs
Knowledge of global medical-device regulatory requirements