Manager Regulatory Operations at Cochlear

Kuala Lumpur, Kuala Lumpur, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

09 Jul, 26

Salary

0.0

Posted On

10 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Device Regulation, Team Leadership, Regulatory Strategy, Lifecycle Management, Regulatory Submissions, Stakeholder Management, Documentation Management, Compliance, Quality Systems, Product Registration, Regulatory Intelligence, Labelling Development, Technical Dossiers, Risk Management, Cross-functional Collaboration

Industry

Medical Equipment Manufacturing

Description

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 Manager - Regulatory Operations leads a team of specialists responsible for supporting product registrations, information management, regulatory intelligence, product requirements, labelling development and maintenance across Cochlear’s 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 Cochlear’s 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 Cochlear’s WHS and injury management procedures including adherence to any local legislative requirements. Minimum Requirements Essential Skills, Qualifications & Experience Bachelor’s 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 Master’s 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 Cochlear’s 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. #CochlearCareers Our growth is creating great opportunities! Our team is expanding and we want to hire the most talented people we can. Continued success depends on it. So once you've had a chance to explore our current open positions, apply to the ones you feel suit you best and keep track of both your progress in the selection process, and new postings that might interest you! We're the global leader in implantable hearing solutions. We have provided more than 600,000 implantable devices, helping people of all ages to lead full and active lives. We help people hear and be heard. We empower people to connect with others and live a full life. We help transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes.

Responsibilities

The Manager of Regulatory Operations leads a team responsible for product registrations, regulatory intelligence, and lifecycle management across global portfolios. They ensure alignment between corporate planning and regional requirements while overseeing submission readiness and regulatory compliance.