Regulatory Affairs Associate

Kuala Lumpur - Malaysia

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

Change peoples 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 peoples lives.

About the Role

We are seeking aRegulatory Affairs Associateto join our teamtosupport the implementation of regulatory strategiesprepareregulatory submissionsandensurecompliancetolabelling requirementsforCochlearsproducts.

In this role you willsupport the preparation and maintenance of regulatory submissions product registrations and renewals in alignment with company and authority requirements.You willcontribute to the development oflabelling requirementsforinstructions for use packaging labels and product informationandcoordinate labelling verification to ensure compliancewith international standards and country-specific regulations.

This position works closely with cross-functional teams includingRegulatoryTechnical CommunicationsMarketingandProduct Developmentto ensureaccurate compliant and effectivelabelling andregulatorydocumentation.

Key Responsibilities:

1. Labelling Compliance and Documentation

Assistinterpretation and application ofglobal and regional medical device labelling standards and regulations.
Support the developmentandmaintenanceofa central repository oflabellingrequirements.
Prepare and deliverlabellingrequirements specificationsverificationreportstestprotocolsand traceability reports.
Support themanagementthe lifecycle and traceability of labelling requirements including theassociated 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 andassistin organizing meetings and communications.

3. Regulatory Submissions and Approvals

Compilesubmit andmaintainregulatory files product license renewals and annual registrations.
Prepare responses to regulatoryauthorityqueries and manage associated documentation.
Track and report submission statuses and ensuretimelyrenewals and compliance.
Support the archiving and retrieval of regulatory documentation asrequired.

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.
Identifyopportunities for process improvement.
Actively support workplace health and safety initiatives.

Qualifications and Experience

Minimum:

Bachelors degree in science Biomedical Engineering ora relateddiscipline.
Strong organizational skillsandexceptional attention to detail.
Excellent written and verbal communication skills.
Proven ability to manage multiple projects and meet deadlines.
Proficiencyin Microsoft Office (Word Excel PowerPoint).
Demonstrated analytical and problem-solving abilities.
Experience working collaboratively with cross-functional teams.

Ideal:

Advanced degree or RACS certification.
23 years of experience inwithin the medical device or pharmaceutical industry ideallyinRegulatory Affairs
Goodunderstanding of regulatory submission processes and medical device regulations.
Proven experience in the preparation and management of regulatory documentation.
Familiarity with requirementsmanagement tools and verificationprocesses anddocumentation.

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 yourexpertisein regulatory compliance will directly contribute to delivering safe and effective products worldwide

Cochlear Malaysia provides shared services to support Cochlears 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.

#CochlearCareers

Required Experience: