Manager Regulatory Operations

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 Manager - Regulatory Operations leads a team of specialists responsible for supporting product registrations information management regulatory intelligence product requirements labelling development and maintenance across Cochlears acoustics and cochlear implant portfolios.

The Manager is responsible for liaising with the EMEA Asia Pacific Latin America and North America regions to ensure alignment of corporate (global) planning with regional requirements.

The role provides guidance across the pre-market and post-market phases ensuring documentation is submission ready and that product and process changes meet global regulatory requirements.

Key Accountabilities

1. Leadership & Team Development

• Provide direction leadership and coaching to the Regulatory Operations team within the Cochlear Malaysia site.

• Develop a strong high performing Regulatory Operations team within the Cochlear Malaysia site.

• Support and lead continuous improvement of regulatory systems processes and deliverables.

• Promote a strong culture of workplace health safety and quality.

• Develop future leaders within the team to support succession planning and sustainable growth.

• Collaborate across multiple Cochlear sites and global teams.

2. Regulatory Strategy & Planning

• Support regulatory planning to enable regulatory strategies regional registrations and business plans.

• Provide regulatory and standards expertise to cross-functional project teams.

• Define regulatory documentation requirements; ensure quality and timely delivery.

• Communicate regulatory risks impacts and opportunities to key stakeholders.

3. Regulatory Submissions & Lifecycle Management

• Oversee preparation and management of submissions for new and modified products.

• Drive the development of labelling and other customer-facing documentation including translation to ensure regional product requirements are met.

• Lead adaptation of technical dossiers for regional regulatory authorities.

• Maintain product and importation licenses throughout the product lifecycle.

• Drive and monitor post-approval commitments and renewal activities.

4. Cross-functional Regulatory Leadership

• Support design manufacturing and labelling changes to maintain regulatory compliance.

• Serve as liaison between regions and global manufacturing for products and projects.

• Assess and communicate regulatory changes and trends; propose implementation plans.

• Lead implementation of improved regulatory practices and processes.

• Support audit and inspection activities as required.

5. Team role: Manager of people

• Demonstrate active involvement in the implementation and improvement of relevant quality procedures.

• Attract develop and retain the best team to deliver Cochlears current and future business objectives for example by:

  • Ensuring clarity of expectations and outcomes for individuals and team

  • Providing regular feedback on performance and alignment with the HEAR behaviours

  • Providing coaching for growth and success to build individual and team capability

• Demonstrate due diligence commitment to workplace health and safety through active involvement and implementation of Cochlears WHS and injury management procedures including adherence to any local legislative requirements.

Minimum Requirements

Essential Skills Qualifications & Experience

• Bachelors degree in engineering legal scientific or healthcare disciplines or equivalent experience.

• Minimum 5-7 years regulatory affairs experience including submission preparation and lifecycle maintenance.

• 5-7 years experience in medical device product or software development.

• Proven track record managing high-performing teams to achieve excellence and career growth.

• Strong understanding of regulations in key markets globally.

• Ability to apply global medical device regulatory requirements.

• Excellent documentation report writing and stakeholder management skills.

• Strong decision-making skills when faced with regulatory ambiguity.

• Relationship building experience including interactions with regulators.

Desired Qualifications

• Masters or doctorate in a relevant field.

• Regulatory Affairs Certification (RAC).

Development Opportunities

In this role the Manager will develop a strong Regulatory Operations team within the Cochlear Malaysia site working closely with teams across multiple global sites to influence how Cochlear delivers regulatory support across international markets. This is an opportunity to help shape and execute changes that improve efficiency scalability and service

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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