Manager, Regulatory Affairs and Quality

Please submit your application as soon as possible, as we reserve the right to close this advertisement at any time.

Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. 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. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.

Position Overview

Reporting to the Director, Regulatory Affairs APAC, this role is responsible for leading Regulatory Affairs and Quality activities across Asia Growth Markets (AGM) and South Asia (SA) to support Cochlear’s growth, market access objectives, and ongoing regulatory compliance.

The successful candidate will develop and execute regulatory strategies, deliver timely product registrations, maintain effective local Quality Management Systems (QMS), oversee post-market surveillance and compliance activities, and build strong relationships with internal stakeholders, distributors, dealers, and regulatory authorities. Additionally, the role provides leadership to a regional team, ensuring capability development and the successful delivery of current and future business objectives.

Key Responsibilities

Regulatory Strategy & Planning

• Partner with Business, Marketing, Market Access, and Government Affairs teams to develop and execute regulatory strategies for new product introductions, renewals, product changes, and product retirement activities.

• Maintain and communicate regional regulatory plans, ensuring alignment across cross-functional teams.

• Contribute to business planning, forecasting, reporting processes, and APAC regulatory and quality budget activities.

• Act as a regional subject matter expert on local regulatory requirements and ensure these are incorporated into product development and lifecycle planning.

• Monitor regulatory trends and legislative changes, recommending strategies to minimise business impact and support ongoing market access.

• Provide regulatory intelligence and insights to regional and global stakeholders.

• Build and maintain effective relationships with local regulatory authorities to facilitate product approvals and market access.

• Identify regulatory compliance risks and support the implementation of mitigation strategies to protect business continuity.

Regulatory Affairs & Product Registration

• Execute product registration plans to ensure timely regulatory approvals.

• Provide clear and timely updates on regulatory status, risks, and approval timelines to key stakeholders.

• Support regional product planning activities by ensuring regulatory requirements are understood and addressed.

• Lead registration strategies and regulatory submission activities across the region.

• Establish and maintain regulatory documentation, files, and licences in accordance with local legislation and internal quality standards.

Quality Management System (QMS)

• Establish and monitor quality objectives and key performance indicators across AGM and SA markets.

• Report QMS compliance status to local management teams and regional/global quality stakeholders.

• Partner with Quality teams to maintain and continuously improve local QMS processes, ensuring compliance with country-specific requirements, including:

  • Singapore and Malaysia Good Distribution Practice (GDP)

  • India Legal Metrology requirements

  • Medical Device Regulations

• Manage quality-related issues and mandatory reporting obligations to regulatory authorities, including CDSCO, HSA, and MDA.

• Lead and support external and third-party audits.

• Oversee local inspection activities relating to product receipt, release processes, and inventory quality control requirements.

• Monitor applicable non-medical device legislation and ensure compliance through established regulatory intelligence processes.

• Drive continuous improvement in quality and regulatory compliance among licence holders, distributors, and dealers.

Post-Market Surveillance & Compliance

• Lead post-market vigilance activities, including complaint handling, adverse event reporting, field actions, and post-market surveillance submissions.

• Ensure all adverse event reporting obligations are met in accordance with local regulatory requirements.

• Review marketing materials, promotional activities, and collateral to ensure compliance with advertising regulations and industry codes.

• Collaborate with Marketing, Clinical, and Business Development teams to ensure activities align with Fair Competition Regulations and applicable legislation.

• Prepare and coordinate Post-Market Surveillance (PMS) submissions required by authorities such as HSA, MDA, and CDSCO.

• Foster a culture of quality, regulatory, and business compliance, providing guidance and support across the organisation.

Leadership Responsibilities

This role includes direct people leadership responsibility and requires an individual who can build and develop a high-performing regional team.

Key responsibilities include:

• Providing leadership and direction across AGM and SA Regulatory Affairs and Quality activities.

• Attracting, developing, and retaining top talent to support current and future business needs.

• Establishing clear expectations, goals, and priorities for team members.

• Delivering regular performance feedback and coaching to support development and growth.

• Supporting workforce planning, workload prioritisation, capability development, and succession planning.

• Demonstrating commitment to Workplace Health and Safety (WHS) through active support of Cochlear’s WHS and injury management procedures.

• Promoting continuous improvement through active engagement with quality processes and procedures.

About You

Essential Requirements

• Degree qualification in a relevant discipline.

• More than 5 years of professional experience in Regulatory Affairs, Quality, Reimbursement, or a related field and minimum of 3 years as a people manager.

• Demonstrated knowledge of medical device and/or pharmaceutical regulations, including product development, registration, approval, and lifecycle management processes.

• Proven experience managing, compiling, submitting, and maintaining regulatory and reimbursement filings.

• Experience working directly with government agencies, regulatory authorities, industry bodies, and healthcare professionals.

• Strong written and verbal communication skills in English.

• Demonstrated leadership capability, including:

  • Sound judgement and decision-making

  • Strong interpersonal and stakeholder management skills

  • Effective communication and influencing abilities

  • Project management capability

  • Ability to build collaboration across diverse teams

Preferred Experience

• Experience supporting the introduction of new medical technologies.

• Country-level management experience.

• Experience managing Regulatory Affairs and Quality activities across multiple APAC markets.

Why Join Cochlear?

This role offers a unique opportunity to influence regulatory and quality strategy across a diverse and rapidly evolving region. You will collaborate closely with Cochlear leadership teams across Asia Pacific, contribute to regional planning and decision-making, and engage with external stakeholders including government agencies, industry representatives, and key opinion leaders.

If you are an experienced regulatory professional who thrives in a strategic, collaborative, and growth-focused environment, we encourage you to apply.

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

How we recognise your contribution

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

For more information about Life at Cochlear, visit www.cochlearcareers.com