Change people's lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives.
About the Role
We are seeking a Regulatory Affairs Associate to join our team to support the implementation of regulatory strategies, prepare regulatory submissions, and ensure compliance to labelling requirements for Cochlear's products.
In this role, you will support the preparation and maintenance of regulatory submissions, product registrations, and renewals in alignment with company and authority requirements. You will contribute to the development of labelling requirements for instructions for use, packaging labels, and product information and coordinate labelling verification to ensure compliance with international standards and country-specific regulations.
This position works closely with cross-functional teams including Regulatory, Technical Communications, Marketing and Product Development, to ensure accurate, compliant, and effective labelling and regulatory documentation.
Key Responsibilities:
1. Labelling Compliance and Documentation
- Assist interpretation and application of global and regional medical device labelling standards and regulations.
- Support the development and maintenance of a central repository of labelling requirements.
- Prepare and deliver labelling requirements specifications, verification reports, test protocols and traceability reports.
- Support the management the lifecycle and traceability of labelling requirements, including the associated change management processes.
2. Regulatory Strategy and Planning
- Support the implementation of regulatory strategies and business plans to meet submission timelines.
- Coordinate and align regulatory activities with marketing and product plans.
- Maintain positive relationships with regulatory authorities and assist in organizing meetings and communications.
3. Regulatory Submissions and Approvals
- Compile, submit, and maintain regulatory files, product license renewals, and annual registrations.
- Prepare responses to regulatory authority queries and manage associated documentation.
- Track and report submission statuses and ensure timely renewals and compliance.
- Support the archiving and retrieval of regulatory documentation as required.
4. Cross-Functional and Compliance Support
- Support the review and approval of clinical study documents, advertising materials, and product labelling.
- Participate in audits and inspections, ensuring all documentation meets quality and regulatory standards.
- Contribute to the assessment of product and design changes, non-conformances, and risk management activities.
- Collaborate with regional teams to ensure consistent compliance across markets.
5. Quality, Safety, and Continuous Improvement
- Adhere to internal quality and regulatory procedures.
- Identify opportunities for process improvement.
- Actively support workplace health and safety initiatives.
Qualifications and Experience
Minimum:
- Bachelor's degree in science, Biomedical Engineering, or a related discipline.
- Strong organizational skills and exceptional attention to detail.
- Excellent written and verbal communication skills.
- Proven ability to manage multiple projects and meet deadlines.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Demonstrated analytical and problem-solving abilities.
- Experience working collaboratively with cross-functional teams.
Ideal:
- Advanced degree or RACS certification.
- 2-3 years of experience in within the medical device or pharmaceutical industry, ideally in Regulatory Affairs
- Good understanding of regulatory submission processes and medical device regulations.
- Proven experience in the preparation and management of regulatory documentation.
- Familiarity with requirements management tools and verification processes and documentation.
Why Join Us
At Cochlear, we are committed to innovation that transforms lives. You will be part of a global organization dedicated to developing medical technologies that make a difference. Join a collaborative environment where your expertise in regulatory compliance will directly contribute to delivering safe and effective products worldwide
