Senior Regulatory Affairs Specialist

Requirements

• Master's 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 medical‑device product or software development.
• Development Value
• Opportunity to develop deep knowledge across Cochlear's 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 Cochlear's global o

Benefits

Additional Information

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. Job Overview & Purpose The Senior Regulatory Affairs Specialist provides regulatory support across the full lifecycle of Cochlear products. This role contributes to both pre‑market and post‑market activities by guiding cross‑functional 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 needs-including EMEA, Asia-Pacific, Latin America, and North America-during corporate regulatory discussions. Key Accountabilities 1. Regulatory Strategy & Planning Provide regulatory and standards‑compliance 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 post‑approval commitments and renewal activities. 3. Cross‑Functional 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 on‑site 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 Bachelor's degree in engineering, legal, scientific, or healthcare discipline. 3-5+ years' experience in product development, quality, or regulatory affairs. Strong report‑writing 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 medical‑device regulatory requirements.

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