Regulatory Affairs Director

5 days ago


Gothenburg, Västra Götaland, Sweden Cochlear Full time
Job Description:

We are seeking a seasoned professional to lead our CBAS Regulatory team in Gothenburg, ensuring compliance and timely approvals for acoustics products in regulated markets worldwide.

Key Responsibilities:
  1. 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.
Operational Excellence:
  • Optimize systems for tracking regulatory submissions and commitments.
  • Lead the team in managing change controls and submission requirements.
Regulatory Compliance:
  • 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.
Team Development:
  • 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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