Regulatory Affairs Specialist

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; Hybride; MYR 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

Cochlear Malaysia SDN BHD. is seeking a Regulatory Affairs Specialist to partner with Product Development and R&D in Kuala Lumpur, guiding regulatory strategy for medical devices and software from concept through market release.

You will prepare submissions to FDA, EU Notified Bodies, and international authorities, ensure compliance across global markets, and work closely with cross‑functional teams to manage lifecycle activities and regulatory changes.

Qualifications

• Bachelor's degree in Engineering, Science, Healthcare, Biomedical, Legal or related discipline (or advanced degree).
• 3–8 years’ experience in regulatory affairs and submissions for Class II/III devices or SaMD.
• Excellent written and verbal communication skills.
• Experience preparing technical documentation, reports and regulatory submissions.
• Proven ability to collaborate and influence within cross-functional and global teams.
• Familiarity with global regulatory requirements and cyber security considerations.

Responsabilités

• Provide regulatory and standards guidance throughout product development and lifecycle.
• Define regulatory pathways and documentation requirements for new products and software releases.
• Prepare and coordinate regulatory submissions to agencies including FDA, EU Notified Bodies and international authorities.
• Develop and maintain regulatory dossiers and ensure timely post-approval activities.
• Collaborate with R&D, Quality and regional regulatory teams to align strategy and execution.

Connaissances

Regulatory affairs

Regulatory submissions

Cross-functional collaboration

Communication skills

Regulatory standards

Formation

Bachelor's degree or advanced degree in related discipline

Advanced degree in Engineering/Science/Healthcare/Legal

Outils

IEC 62304

ISO 13485

ISO 14971

Description du poste

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. We are currently seeking a Regulatory Affairs Specialist to join our Global Regulatory Affairs team based in Kuala Lumpur.

This is an exciting opportunity to partner directly with Product Development and R&D teams, influencing the regulatory strategy of medical devices and software solutions used by thousands of hearing implant recipients worldwide. Unlike traditional market-facing regulatory roles, this position plays a critical role within the product development lifecycle, ensuring innovative products and software solutions are developed with global regulatory requirements in mind from concept through commercialization.

About the Role As a Regulatory Affairs Specialist, you will provide regulatory expertise throughout the lifecycle of Cochlear products, supporting both pre-market development activities and post-market software sustaining activities.

You will work closely with global cross-functional teams to define regulatory strategies, assess product and software changes, ensure submission readiness of technical documentation, and support regulatory approvals across major international markets. This role supports a global product portfolio with primary exposure to the United States and European regulatory environments, while collaborating with regulatory teams across APAC, EMEA, Latin America and North America.

What You’ll Be Doing

Regulatory Strategy & Product Development Support

• Partner with R&D and cross-functional project teams to provide regulatory and standards compliance advice throughout product development.
• Define regulatory pathways and documentation requirements for new products and software releases.
• Support the development of regulatory strategies that align with business objectives and global market access plans.
• Assess Design History File (DHF) deliverables to ensure submission readiness.
• Evaluate the impact of regulatory activities on product launch and commercialization plans.

Regulatory Submissions & Lifecycle Management

• Prepare and coordinate regulatory submissions to agencies including FDA, EU Notified Bodies and international regulatory authorities.
• Support approvals for new products, software releases and manufacturing changes.
• Develop, adapt and maintain technical documentation and regulatory dossiers required for global registrations.
• Monitor submission progress and ensure timely completion of post-approval commitments and renewals.

Software & Regulatory Change Assessment

• Assess software updates, design modifications, labelling changes and promotional materials for regulatory impact.
• Provide guidance on software-related regulatory requirements and associated documentation needs.
• Support the evaluation of software risks, including cybersecurity, validation and data privacy considerations.
• Collaborate with development teams to ensure regulatory expectations are incorporated into software development activities.

Regulatory Leadership & Cross-functional Collaboration

• Act as a trusted regulatory partner to R&D and product development teams.
• Work closely with regional regulatory teams to support global registrations and submissions.
• Support CAPA Review Boards and regulatory compliance activities.
• Monitor emerging global regulations and advise stakeholders on potential business impacts.
• Represent Regulatory Affairs at project meetings, forums, audits and inspections as required.

What Success Looks Like

In this role, you will become the regulatory voice within product development teams, helping shape innovative medical device and software solutions from early concept through to market approval. The successful candidate will demonstrate the ability to:

• Balance regulatory compliance with business objectives.
• Influence stakeholders across a matrix organization.
• Navigate ambiguity and make sound regulatory judgments.
• Build effective partnerships with R&D, Quality and regional Regulatory Affairs teams.
• Proactively identify regulatory risks and recommend practical solutions.

About You Required Qualifications & Experience

Bachelor's Degree in Engineering, Science, Healthcare, Biomedical, Legal or a related discipline or Advanced degree in Engineering, Scientific, Healthcare or Legal disciplines.

Excellent written and verbal communication skills.

Experience preparing strong technical documentation, reports and regulatory submissions.

Proven ability to collaborate and influence within cross-functional and global teams.

3-8 years' experience in: Regulatory affairs and regulatory submissions for Class II or Class III devices, or Software quality, systems engineering, software validation, or software compliance, ideally in a regulated industry.

Desired Qualifications & Experience

• Exposure to IEC 62304, ISO 14971, ISO 13485, or cybersecurity requirements.
• Experience participating in design reviews and change assessments.
• Strong understanding of medical device regulatory requirements.

What Will Make You Stand Out

• Experience with Software as a Medical Device (SaMD) or regulated healthcare software.
• Exposure to FDA, EU MDR or other global regulatory frameworks.
• Understanding of software validation, software development lifecycle and risk management.
• Familiarity with cybersecurity and data privacy considerations within regulated products.
• Experience supporting R&D or product development teams.
• Regulatory Affairs Certification (RAC).

Why Join Cochlear?

Join a global medical technology leader that transforms lives through hearing innovation.

Work on cutting-edge implantable medical devices and software technologies.

Gain exposure to global regulatory strategy and international product development projects.

Collaborate with highly experienced regulatory, engineering and product development professionals across multiple regions.

Enjoy a hybrid working arrangement with standard Malaysian working hours.

Build a long-term global career within a mission-driven organization.

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.