Senior 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.

Job Overview & Purpose

The Senior Regulatory Affairs Specialist provides regulatory support across the full lifecycle of Cochlear products. This role contributes to both premarket and postmarket activities by guiding crossfunctional teams on global regulatory requirements and ensuring documentation is ready for regulatory submissions. It also evaluates product and process changes advises on required verification and validation and supports submissions and regulatory interactions across global regions.

The position serves as a primary liaison between global regions and R&D teams to address regulatory inquiries resolve issues and provide technical support. It also represents regional regulatory needsincluding EMEA Asia-Pacific Latin America and North Americaduring corporate regulatory discussions.

Key Accountabilities

1. Regulatory Strategy & Planning

• Provide regulatory and standardscompliance guidance throughout product development.

• Define regulatory documentation requirements and ensure deliverables meet quality and timeline expectations.

• Manage regulatory planning to support business objectives and regional registration strategies for assigned products or projects.

• Communicate proactively about the impact of regulatory activities on business and marketing plans.

2. Regulatory Submissions & Lifecycle Maintenance

• Prepare coordinate and manage submissions required to obtain new or modified product approvals; maintain product licences across the portfolio.

• Develop adapt and maintain technical dossiers to meet regional regulatory requirements working closely with regional offices and distributors.

• Ensure timely submissions and approvals related to manufacturing changes.

• Implement and maintain strategies to ensure ongoing compliance with product and importation licensing requirements across the product lifecycle.

• Monitor track and complete postapproval commitments and renewal activities.

3. CrossFunctional Regulatory Direction

• Assess design manufacturing and labelling changes for regulatory impact; articulate changes clearly for regions and regulators.

• Provide regulatory input to CAPA Review Boards (if required).

• Analyse and communicate emerging regulatory requirements or trends assess their impact on the business and propose implementation plans.

• Champion regulatory practices and continuous improvement initiatives.

• Represent Regulatory Affairs in project meetings and communicate regulatory positions as required.

• Support onsite inspections and audits when required.

4. Team Contribution & Quality

• Follow quality procedures to deliver compliant products and services; support continuous improvement initiatives.

• Lead implementation and improvement of systems and processes that enhance regulatory deliverables.

• Demonstrate commitment to workplace health and safety by following WHS procedures and participating in injury management processes.

• Undertake additional quality responsibilities such as auditing when appropriately trained.

• Work safely comply with safety rules and report hazards or incidents promptly.

Minimum Requirements

Required Skills & Qualifications

• Bachelors degree in engineering legal scientific or healthcare discipline.

• 3-5 years experience in product development quality or regulatory affairs.

• Strong reportwriting and documentation skills.

• Ability to influence and collaborate effectively in a matrix environment.

• Proven ability to manage stakeholders across all levels of the business.

• Sound judgment and the ability to provide regulatory advice balancing business needs and regulatory risk. Comfortable making decisions in ambiguous conditions.

• Ability to communicate with and build effective relationships with regulators.

• Knowledge of global medicaldevice regulatory requirements.

Desired Skills

• Masters or doctorate degree in engineering legal scientific or healthcare field.

• Regulatory Affairs Certification (RAC).

Work Experience

• 3 years experience in regulatory affairs including preparation submission and maintenance of regulatory filings.

• 3 years experience in medicaldevice product or software development.

Development Value

• Opportunity to develop deep knowledge across Cochlears product portfolio and engage with teams across multiple sites.

• Build strong understanding of global standards guidelines and regulatory directives.

• Contribute to transformation of regulatory practices that improve efficiency scalability and service delivery

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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