Regulatory Affairs Specialist (Medical Devices & Software)

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; Hybrid; MYR 120.000 - 200.000; Vollzeit

Benefits dieser Stelle

Hybrid working arrangement

Zusammenfassung

Cochlear Malaysia Sdn Bhd is seeking a Regulatory Affairs Specialist (Medical Devices & Software) in Kuala Lumpur to partner with Product Development and R&D, shaping regulatory strategy for devices and SaMD used worldwide.

The role covers pre- and post-market activities, worldwide registrations, and collaboration with regional/regional teams to ensure compliant product development and market access.

Qualifikationen

• Bachelor's degree or higher in Engineering, Science, Healthcare, Biomedical, Legal or related field.
• Excellent written and verbal communication skills.
• Experience preparing technical documentation and regulatory submissions.
• Ability to collaborate and influence within cross-functional and global teams.
• 3–8 years' experience in regulatory affairs for medical devices or SaMD.

Aufgaben

• Provide regulatory expertise throughout product lifecycle and support pre-market development and post-market software activities.
• Define regulatory strategies and documentation requirements for new products and software releases.
• Coordinate regulatory submissions to FDA, EU Notified Bodies and other authorities.
• Develop and maintain technical documentation and regulatory dossiers for global registrations.
• Assess software changes for regulatory impact and support risk management considerations.

Kenntnisse

Regulatory strategy

Regulatory submissions

Documentation excellence

Cross-functional collaboration

DHF & regulatory dossiers

Regulatory impact assessment

Ausbildung

Bachelor's degree in Engineering/Science/Healthcare/Legal

Advanced degree preferred

Tools

Regulatory submissions process

Regulatory databases

Jobbeschreibung

Regulatory Affairs Specialist (Medical Devices & Software)

We are currently seeking a Regulatory Affairs Specialist (Medical Devices & Software) 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).
• 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.

For over 30 years, Cochlear has been the global leader in implantable hearing solutions and has helped 750,000 recipients worldwide. This is an exciting and challenging time to join Cochlear, as we strengthen our expanding global business to support sustained growth and drive continual improvement. We look forward to your contribution in helping us achieve this goal by embracing change, demonstrating a global mindset, promoting innovation, thinking towards the future, and going beyond what you thought was possible.

What can I earn as a Regulatory Affairs Specialist