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Regulatory Affairs Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time
Job Summary

We are seeking a skilled Regulatory Affairs Specialist to join our team at Vectura Group. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.

Key Responsibilities:
  • Lead regulatory activities across the company to support product approvals and ensure alignment with corporate goals.
  • Contribute to the regulatory strategy and execution of global regulatory submissions in accordance with the Medical Device Directive (MDD) and Medical Device Regulations (MDR).
  • Collaborate effectively with teams in regulatory, quality assurance, and device engineering to ensure seamless regulatory support and compliance throughout product development and commercialization.
Requirements:
  • Proven experience in Regulatory Affairs, particularly in medical devices and drug-device combination products.
  • In-depth knowledge of MDD, MDR, ISO standards, FDA regulations, and other relevant global regulatory frameworks.
  • Experience authoring MDR Technical Files, Design Dossiers, and other regulatory submissions.
  • Strong understanding of regulatory submissions, including interaction with regulatory authorities and notified bodies.
  • Excellent cross-functional collaboration skills with teams in regulatory, quality, and engineering.
  • Project management experience in regulatory projects such as EUDAMED or UKCA.
Benefits:
  • $90,000 - $110,000 per year, depending on experience.
  • A dynamic work environment and opportunities for professional development.
  • A collaborative culture dedicated to achieving excellence.