About This Role
This role is a Regulatory Affairs Specialist within the Global Regulatory Affairs team, focusing on medical devices and software solutions. The specialist partners with Product Development and R&D teams to influence regulatory strategy from concept through commercialization, ensuring products meet global regulatory requirements. This position supports a global product portfolio with primary exposure to the United States and European regulatory environments.
Responsibilities
- Provide regulatory expertise throughout the lifecycle of Cochlear products, supporting pre-market development activities and post-market software sustaining activities
- Work closely with global cross-functional teams to define regulatory strategies
- Assess product and software changes
- Ensure submission readiness of technical documentation
- Support regulatory approvals across major international markets
- 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
- 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
- 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
- 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
