Launch your regulatory career with the leader in medical hearing technology. Cochlear is seeking a detail-oriented Regulatory Affairs Associate to join our team in Malaysia. In this role, you will play a crucial part in ensuring global regulatory compliance, with a special focus on developing and verifying product labelling and supporting submissions for our life-changing devices. This is a perfect opportunity to build your expertise within a collaborative, global function dedicated to bringing innovative healthcare solutions to market.
Key Responsibilities
You will support the end-to-end regulatory process, with a significant focus on labelling compliance and submission management.
Labelling Compliance & Management:
- Interpret and apply global medical device labelling standards and regulations to ensure compliance.
- Support the development and maintenance of a central repository for labelling requirements.
- Prepare labelling requirement specifications, verification reports, and test protocols.
- Manage the lifecycle and traceability of labelling through change management processes.
Regulatory Submissions & Strategy:
- Support the implementation of regulatory strategies to meet submission timelines for new products and renewals.
- Compile, submit, and maintain regulatory files, product license renewals, and annual registrations.
- Prepare responses to regulatory authority queries and track submission statuses.
Cross-Functional Collaboration & Support:
- Collaborate with Regulatory, Technical Communications, Marketing, and Product Development teams.
- Support the review of clinical study documents, advertising materials, and product labelling.
- Participate in audits and contribute to the assessment of product changes and risk management.
Qualifications & Experience
Essential Qualifications:
- Bachelor’s degree in Science, Biomedical Engineering, or a related discipline.
- Strong organizational skills with exceptional attention to detail.
- Excellent written and verbal communication skills.
- Proven ability to manage multiple projects and deadlines in a collaborative team environment.
- Proficiency in Microsoft Office Suite.
Ideal Qualifications:
- 2–3 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry.
- Good understanding of medical device regulations and submission processes.
- Experience with requirements management tools and verification documentation.
- RACS certification or an advanced degree.
Why Join Cochlear?
When you join Cochlear, you help create a sound future for millions of people worldwide. Based in our growing Malaysian shared services centre, you will:
- Make a Tangible Impact: Your work ensures safe, compliant products that restore hearing.
- Grow Your Career: Build specialized expertise in medical device regulatory affairs and labelling.
- Join a Supportive Global Team: Collaborate with professionals across the globe in a values-driven culture.
Ready to help people hear and be heard? If you have the skills and motivation to succeed in this role, we encourage you to apply.
