Bring Life-Changing Hearing Technology to the World
Cochlear is the global leader in implantable hearing solutions. Our mission is to help people hear and be heard. As a top 100 medical device company, more people choose a Cochlear hearing implant than any other. Our employees say the number one reason they love working here is the opportunity to make a profound difference in people's lives.
Join our global shared services centre in Kuala Lumpur and play a pivotal role in bringing our life-changing technology to patients across APAC, LATAM, and EMEA regions.
Your Impact
As a Regulatory Affairs Specialist, you will provide critical regulatory support across the product lifecycle, managing international submissions, approvals, and compliance activities. You will ensure Cochlear products meet diverse regulatory requirements, enabling market access and improving patient access to hearing solutions worldwide. This role offers exceptional development value with broad exposure to global product portfolios and regulatory frameworks.
Your Key Accountabilities
International Registration & Submissions:
- Plan, prepare, and deliver documentation for product submissions and approvals in international markets.
- Manage the preparation and legalization of regional documentation.
- Maintain accurate submission records and track regional requests using systems like JIRA.
- Support regional tenders and business activities with regulatory expertise.
Cross-Functional Regulatory Guidance:
- Monitor and interpret changes in national regulations, assessing impact and proposing implementation plans.
- Provide regulatory guidance to cross-functional teams, promoting best practices.
- Support audit activities and on-site regulatory inspections as required.
Compliance & Documentation:
- Assist in interpreting and applying global and regional medical device standards and regulations, including labelling requirements.
- Support the development and maintenance of a central repository of product requirements.
- Prepare labelling specifications, verification reports, and traceability documentation.
Project Support & Team Contribution:
- Contribute to the assessment of product/design changes, non-conformances, and risk management.
- Follow quality procedures and support continuous improvement of regulatory systems and processes.
- Demonstrate commitment to workplace health and safety.
Your Profile: Minimum Requirements
- Bachelor’s degree in Biomedical Engineering, Engineering, Science, or a related discipline.
- 3+ years of relevant experience in product development, quality, or regulatory affairs.
- Strong working knowledge of global medical device regulatory requirements.
- Exceptional organisational skills and attention to detail.
- Excellent written and verbal communication skills in English.
- Proven ability to manage multiple projects, meet deadlines, and write clear reports.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Ability to work collaboratively in cross-functional or matrix teams.
Ideal Qualifications (Advantageous):
- Advanced degree or RACS certification.
- 3+ years in the medical device or pharmaceutical industry, ideally in Regulatory Affairs.
- Hands-on experience preparing and managing international regulatory submissions.
- Familiarity with requirements-management tools and verification processes.
- Experience in medical device or software development.
Why Join Cochlear Malaysia?
- Purpose-Driven Work: Your expertise directly helps bring life-changing hearing technology to patients worldwide.
- Global Career Development: Gain broad exposure to international regulations and diverse product portfolios.
- Shared Services Hub: Be part of a growing, professional team supporting Cochlear's global operations.
- Inclusive & Supportive Culture: Join a values-driven company where you can build a long-term career.
If you have the skills and passion to navigate the complex world of medical device regulations, we encourage you to apply.
Ready to help more people hear and experience life's opportunities?
Apply now for the Regulatory Affairs Specialist position in Kuala Lumpur.
#CochlearCareers
Cochlear is proud to be an equal opportunity employer.
