
Director of Regulatory Compliance
5 days ago
The Director of Regulatory Affairs will lead our CBAS Regulatory team in Gothenburg, ensuring compliance and timely approvals for acoustics products in regulated markets worldwide.
Key Responsibilities:- Strategic Leadership:
- Develop and execute global regulatory strategies.
- Provide critical regulatory insights for Cochlear's Product Innovation Process (PIP).
- Present strategic recommendations to CBAS leaders and Regional Regulatory teams.
- Oversee multiple high-priority projects, ensuring successful outcomes.
- Forge strong relationships and negotiate with external regulatory bodies.
- Communicate effectively with all stakeholders to foster teamwork and alignment.
- Deliver impactful business and technical briefings to key stakeholders.
- Optimize systems for tracking regulatory submissions and commitments.
- Lead the team in managing change controls and submission requirements.
- Ensure adherence to European regulatory requirements.
- Review and approve labelling materials.
- Address adverse event filings and participate in regulatory audits and inspections.
- Maintain QMS procedures related to Regulatory Affairs.
- Attract, develop, and retain top talent to achieve Cochlear's business objectives.
- Provide regular feedback and coaching to foster growth and success.
- Champion workplace health and safety initiatives.
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Gothenburg, Västra Götaland, Sweden Cochlear Full timeRole Summary:As the Director of Regulatory Affairs, you will play a pivotal role in leading our Regulatory team in Gothenburg and ensuring compliance and timely approvals for acoustics products worldwide. This is an excellent opportunity to work with a global leader in implantable hearing solutions and make a significant impact on a global scale.The ideal...
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