Regulatory Affairs Specialist

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.

Overview & Purpose

The Regulatory Affairs Specialist provides regulatory support across the lifecycle of Cochlear products focusing on submissions and approvals in APAC LATAM and EMEA markets.

The role contributes regional requirements to global planning provides regulatory guidance and manages regionspecific documentation for submissions tenders and legalization.

The specialist oversees regulatory information management to maintain accurate product and certification records. Additionally the specialist supports engineering and manufacturing teams by assessing product and process changes for regulatory impact.

The role may also be required to contribute to the development of product requirements including for instructions for use packaging labels and product information and undertake verification to ensure compliance with international standards and country-specific regulations.

Accountabilities:

1. International Registration Support

• Plan and deliver documentation required for product submissions and approvals.

• Help identify efficient compliant solutions to address country-specific regulatory requirements.

• Prepare and adapt regional documentation including legalized documents where required.

• Collaborate with crossfunctional SMEs to resolve regulatory queries.

• Contribute to improvements which create registration efficiency and accelerate approvals.

• Maintain accurate submission records and ensure timely updates and closure of regional requests (e.g. JIRA).

• Support regional tenders and business activities.

2. Cross-Functional Regulatory Guidance

• Monitor changes in national regulations assess their impact and propose implementation plans.

• Support integration of new regulations into the QMS.

• Promote improved regulatory practices and processes.

• Contribute to audit activities and on-site inspections as needed.

and Documentation

• Assist interpretation and application of global and regional medical device product standards and regulations including labelling.

• Support the development and maintenance of a central repository of product requirements.

• Prepare and deliver labelling requirements specifications verification reports test protocols and traceability reports.

• Support the management of the lifecycle and traceability of requirements including the associated change management processes.

4. Cross-Functional and Compliance Support (as required)

• 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. Team Contribution

• Follow quality procedures and support continuous improvement.

• Support improvements to systems and processes that enhance deliverables.

• Demonstrate commitment to workplace health and safety as per Cochlears WHS and injury management procedures.

Minimum Key Requirements:

• Bachelors degree in biomedical engineering engineering science or a related discipline.

• 3 years experience in product development quality or regulatory affairs.

• Strong organisational skills and exceptional attention to detail.

• Excellent written and verbal communication skills with strong English proficiency.

• Proven ability to write clear reports and manage documentation effectively.

• Ability to work collaboratively within crossfunctional or matrix teams.

• Demonstrated sound judgment and ability to manage multiple projects and meet deadlines.

• Working knowledge of global medical device regulatory requirements.

• Proficiency in Microsoft Office (Word Excel PowerPoint).

• Strong analytical and problemsolving abilities.

Ideal to have:

• Advanced degree or RACS certification.

• 3 years experience in the medical device or pharmaceutical industry ideally in Regulatory Affairs.

• Strong understanding of medical device regulations and regulatory submission processes.

• Proven experience preparing and managing regulatory documentation.

• Familiarity with requirementsmanagement tools verification processes and related documentation.

• Demonstrated success managing international regulatory submissions.

• Experience in medical device or software development.

Development Value:

• Broad exposure to multiple product portfolios and manufacturing sites.

• Deepening expertise in global standards guidelines and regulatory frameworks.

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.

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