Regulatory Operations Manager - Projects

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 180,000 - 300,000; Full time

Job summary

Cochlear Malaysia SDN BHD. is seeking an experienced Regulatory Operations Manager – Projects in Kuala Lumpur to lead a multi-functional PM team and drive delivery excellence across Regulatory, Content Development, Localisation and Quality.

You will coach Project Managers and Coordinators, manage key projects, and ensure compliance and readiness across global operations. The role emphasizes leadership, process improvement, and collaboration with regional and global partners to support scalable

Qualifications

• Minimum 8 years of experience leading project delivery in regulated industries.
• Experience coaching and leading project/operational delivery teams.
• Strong planning, stakeholder management, and communication skills.

Responsibilities

• Provide day-to-day leadership and coaching to the Kuala Lumpur PM team.
• Lead end-to-end planning and delivery of regulatory projects.
• Coordinate activities across Regulatory, Content Development, Localisation and Quality.
• Maintain project plans, risks, and delivery commitments.

Skills

Team Leadership

Project Management

Stakeholder Management

Regulatory Affairs

English Fluent

Education

Bachelor's degree in Business/Engineering

PM Certification

Tools

Windchill

Jira

Confluence

SharePoint

RIMS

Job 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.

About the Role

We are seeking an experienced Regulatory Operations Manager – Projects to lead the day-to-day coordination, operational support, and delivery oversight of our Kuala Lumpur-based Regulatory Operations Project Management team. This role combines people leadership and hands-on project delivery, supporting Regulatory, Content Development, Localisation, Quality, and related operational functions. You will provide coaching and guidance to Project Managers, Associate Project Managers, and Project Coordinators, while directly managing key projects and workstreams to ensure successful delivery. The successful candidate will play a critical role in driving delivery excellence, improving team capability, maintaining operational visibility, and supporting scalable ways of working across a global and highly collaborative environment.

Key Responsibilities

Team Leadership & Delivery Oversight Provide day-to-day leadership, coaching, and operational support to the Kuala Lumpur Regulatory Operations Project Management team. Support team capability development, onboarding, knowledge sharing, and adoption of best practices in project delivery and stakeholder management. Facilitate delivery reviews, action tracking, operational check-ins, and team coordination activities. Promote consistent project management standards, workflow discipline, communication practices, and execution excellence across the team. Support team members in resolving operational issues, workflow challenges, and delivery blockers.

Project Delivery & Operational Management Lead end-to-end planning and delivery of assigned Regulatory Operations projects and workstreams. Develop and maintain project plans, timelines, milestones, dependencies, risks, and deliverables. Coordinate activities across Regulatory, Content Development, Localisation, Quality, Operations, vendors, regional teams, and other stakeholders. Monitor project progress, manage risks and dependencies, and ensure deliverables meet quality, compliance, and readiness requirements. Maintain visibility of project status, actions, decisions, risks, and delivery commitments.

Workload Planning, Prioritisation & Escalation Management Maintain visibility of team workload, delivery capacity, resource demands, and operational bottlenecks. Support workload balancing and prioritisation across the Kuala Lumpur Project Management team. Identify delivery risks arising from competing priorities, resource constraints, stakeholder dependencies, or incomplete inputs. Escalate significant delivery issues, governance concerns, prioritisation conflicts, and resource challenges to leadership with recommended solutions. Ensure delegated activities remain aligned with broader project and operational objectives.

Stakeholder Management, Systems & Continuous Improvement Build strong working relationships with internal teams, vendors, regional stakeholders, and global partners. Support collaboration across functions, locations, and time zones to enable effective project execution. Oversee project workflows and reporting across systems such as Windchill, Jira, Confluence, TMS, CCMS, RIMS, SharePoint, and related platforms. Ensure accurate documentation, reporting, workflow tracking, and audit readiness across project activities. Drive continuous improvement initiatives by identifying process gaps, workflow inefficiencies, and opportunities to enhance delivery effectiveness and team capability.

Requirements

Minimum 8 years of experience leading project delivery, operational workstreams, or project management teams within regulated industries such as medical devices, pharmaceuticals, biotechnology, healthcare technology, life sciences, or similar environments.

Demonstrated experience managing, mentoring, coaching, or leading project and operational delivery teams.

Strong project planning, stakeholder management, communication, coordination, and problem-solving skills.

Proven ability to manage multiple priorities while maintaining visibility and control across complex projects and operational activities.

Experience working within global or matrix organisations and collaborating across different functions, regions, and time zones.

Ability to effectively manage delivery challenges, resource constraints, and operational risks while escalating broader governance matters when required.

Fluent in English, with strong written and verbal communication skills.

Preferred Qualifications

Experience in Regulatory Affairs, Technical Documentation, Localisation, Quality Systems, or related operational environments.

Familiarity with Windchill, Jira, Confluence, TMS, CCMS, RIMS, SharePoint, or similar workflow and document management systems.

Experience working within shared services, Centres of Excellence (CoE), or global delivery models.

Experience supporting coaching, onboarding, capability development, and team performance improvement initiatives.

Formal project management, program management, operations management, or leadership training/certification is an advantage.

Education

Degree in Business, Science, Engineering, Communications, Regulatory Affairs, Healthcare, or a related discipline.

Leadership, management, project management, or program management qualifications are desirable.

Why Join Us?

Lead and develop a high-performing project management team supporting global operations. Work with international stakeholders across Regulatory, Quality, Content Development, and Localisation. Drive process improvements, operational excellence, and scalable delivery practices. Contribute to impactful projects within a collaborative, innovative, and highly regulated environment. Grow your leadership capability while influencing the future of Regulatory Operations delivery.

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.

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.