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.

As a Senior Regulatory Affairs Specialist, you support the approval and registration of medical devices in international markets (APAC, LATAM, and EMEA). You act as the main contact between regional teams and internal project teams, helping with regulatory requests, document preparation, and compliance.

This role also provides regulatory support to engineering and manufacturing teams, specifically by assessing product and process changes and providing regulatory advice on required V&V and other supportive documentation.

Key Responsibilities:

Support Product Approvals: Help prepare and manage documents needed for product registration in international markets.
Liaise with Teams: Work closely with regional teams and internal departments to resolve regulatory issues and ensure smooth communication.
Document Handling: Assisting with the preparation of region/country specific documentation, including obtaining document legalization.
Regulatory Advice: Advise on product and process changes to ensure they meet regulatory standards.
Compliance Monitoring: Stay updated on changing regulations and help implement them into company processes.
Records Management: Support the maintenance of regulatory information management systems.
Audit Support: Assist during audits and inspections when needed.

Skills & Qualifications:

Masters/Bachelor’s Degree in Legal, Engineering, Science, Law, Healthcare or equivalent.
Minimum of 3+ years of experience in regulatory affairs, quality, medical device development or an equivalent field.
Strong writing and documentation skills.
Good at working with cross-functional teams and managing stakeholders.
Able to interpret and apply global medical device regulations.
Regulatory Affairs Certification (RAC) is a plus.

Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.

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