Regulatory Affairs Specialist

2 days ago

Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time
Regulatory Leadership

Vectura Group, a global leader in inhaled therapies and drug-device combination products, seeks a seasoned Regulatory Affairs Manager to drive the success of our medical device and DDCP regulatory activities.

  1. Regulatory Expertise: Lead regulatory activities across Vectura Group, specializing in medical devices and DDCPs, to support product approvals and align with corporate goals.
  2. Submission & Compliance: Contribute to the regulatory strategy and execution of global regulatory submissions in accordance with MDD and MDR. Author and maintain MDR Technical Files, Design Dossiers, and ensure devices comply with national and international regulatory requirements.
  3. Cross-Functional Collaboration: Collaborate effectively with regulatory, quality assurance, and device engineering teams to ensure seamless regulatory support and compliance throughout product development and commercialization.
  4. Product Development Support: Provide regulatory guidance for new product evaluations and ongoing device development activities, including risk management, human factors, biocompatibility, and clinical evaluations.
  5. Regulatory Intelligence: Stay up-to-date on global regulatory changes, new ISO standards, ICH guidelines, FDA regulations, and other guidance. Conduct impact assessments and ensure the business adapts to evolving regulatory landscapes.
  6. Regulatory Documentation: Prepare and submit regulatory documentation, including communication with regulatory authorities and notified bodies.
  7. Technical Documentation & Maintenance: Maintain and archive technical documentation and regulatory files, including regular review and updates to ensure ongoing compliance with current standards and legal requirements.
  8. Change Impact Assessments: Perform impact assessments on planned changes to medical devices, documenting regulatory impacts through assessment checklists and overseeing necessary updates to regulatory files.
  9. Project Leadership: Lead and support strategic regulatory projects such as EUDAMED, UKCA marking, Quality System Management Reviews, and the development of new devices.
  10. Clinical & Commercial Strategy: Contribute to the regulatory strategy for clinical trial and commercial activities, ensuring alignment with local legislation, language requirements, and registration protocols.
  11. Verification & Validation Support: Assist in the planning, implementation, and documentation of verification and validation activities for device development projects.
  12. Regulatory Newsletter & Intelligence: Contribute to Vectura's Regulatory Newsletter and provide insights on relevant regulatory updates.
  13. Leadership Support: Provide support to the Head of Regulatory Affairs and senior management on key initiatives related to medical devices and regulatory compliance.

Qualifications & Experience:

  1. Proven experience in Regulatory Affairs, particularly in medical devices and drug-device combination products.
  2. In-depth knowledge of MDD, MDR, ISO standards, FDA regulations, and other relevant global regulatory frameworks.
  3. Experience authoring MDR Technical Files, Design Dossiers, and other regulatory submissions.
  4. Strong understanding of regulatory submissions, including interaction with regulatory authorities and notified bodies.
  5. Excellent cross-functional collaboration skills with teams in regulatory, quality, and engineering.
  6. Project management experience in regulatory projects such as EUDAMED or UKCA.
  7. Strong attention to detail, problem-solving, and regulatory intelligence capabilities.

Vectura offers a dynamic work environment, opportunities for professional development, and a collaborative culture dedicated to achieving excellence in medical technology.

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