đ Ensure Global Compliance for Life-Changing Hearing Solutions
Change peopleâs 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 peopleâs lives.
About the Role
We are seeking a Regulatory Affairs Associate to join our team in supporting the implementation of regulatory strategies, preparing regulatory submissions, and ensuring compliance with labelling requirements for Cochlearâs life-changing products.
In this role, you will support the preparation and maintenance of regulatory submissions, product registrations, and renewals in alignment with global requirements. You will contribute to the development of labelling requirements for instructions for use, packaging, and product information, and coordinate labelling verification to ensure compliance with international standards and country-specific regulations.
This position works closely with Regulatory, Technical Communications, Marketing, and Product Development teams to ensure accurate, compliant, and effective labelling and regulatory documentation.
đ Location:Â Kuala Lumpur, Malaysia (Shared Services Hub)
đ Key Responsibilities:
đˇď¸ 1. Labelling Compliance and Documentation
- Assist in interpreting and applying global and regional medical device labelling standards and regulations.
- Support the development and maintenance of a central repository of labelling requirements.
- Prepare labelling requirement specifications, verification reports, test protocols, and traceability reports.
- Manage the lifecycle and traceability of labelling requirements, including change management processes.
đď¸ 2. 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, ensuring timely renewals and compliance.
- Support the archiving and retrieval of regulatory documentation.
đ 3. 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 documentation meets quality and regulatory standards.
- Contribute to the assessment of product changes, non-conformances, and risk management activities.
- Collaborate with regional teams to ensure consistent compliance across markets.
đ 4. Quality, Safety, and Continuous Improvement
- Adhere to internal quality and regulatory procedures.
- Identify opportunities for process improvement.
- Actively support workplace health and safety initiatives.
đ¤ Qualifications and Experience:
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Minimum Requirements:
- Bachelorâs 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.
đ Ideal Qualifications:
- Advanced degree or RACS certification.
- 2â3 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry.
- Good understanding of regulatory submission processes and medical device regulations.
- Experience in preparation and management of regulatory documentation.
- Familiarity with requirements management tools and verification processes.
đź Why Join Cochlear?
- Meaningful Impact: Ensure global compliance for products that restore hearing and transform lives.
- Career Development: Grow your expertise in medical device regulatory affairs and labelling compliance.
- Collaborative Environment: Work with cross-functional global teams in a supportive, innovative setting.
- Shared Services Hub: Be part of Cochlearâs growing Malaysia team supporting worldwide operations.
- Inclusive Culture: Join a company where making a difference is at the core of everything we do.
đ Ready to Launch Your Regulatory Career in Medical Devices?
đ Apply Now for the Regulatory Affairs Associate Role.
#CochlearCareers
Cochlear is an equal opportunity employer committed to diversity, inclusion, and helping people hear and be heard.
