Head of Regulatory Affairs and Compliance
24 hours ago
Cochlear Limited is seeking a dynamic Director of Regulatory Affairs to lead our CBAS Regulatory team based in Gothenburg, Sweden. As Director of Regulatory Affairs, you will be responsible for shaping and executing global regulatory strategies, ensuring compliance and timely approvals for our acoustics products in regulated markets worldwide.
About the TeamYou will be part of a dynamic team that works collaboratively to achieve our business objectives. The ideal candidate will have a strong understanding of healthcare, regulatory affairs, and medical devices, and be able to communicate effectively with all stakeholders.
The key responsibilities of this role include:
- Strategic leadership: Shape and execute global regulatory strategies, mentor and guide your team to provide critical regulatory insights for our Product Innovation Process (PIP), present strategic recommendations to our leaders and regional regulatory teams.
- Operational excellence: Develop and optimize systems for tracking regulatory submissions and commitments, lead the team in managing change controls and submission requirements.
- Regulatory compliance: Serve as our appointed Person Responsible for Regulatory Compliance (PRRC), review and approve labelling materials, address European regulatory requirements for recalls and adverse event filings, participate in regulatory audits and inspections, maintain QMS procedures related to Regulatory Affairs.
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