Regulatory Affairs Specialist

4 weeks ago

Cambridgeshire, United Kingdom Vectura Group Full time
Regulatory Affairs Manager

Vectura Group is a global leader in developing innovative inhaled therapies and drug-device combination products (DDCPs). Our focus is on delivering cutting-edge solutions that improve patient outcomes across a variety of therapeutic areas.

Key Responsibilities:
  • Regulatory Leadership: Assume the role of Regulatory Affairs Manager with specialized expertise in medical devices and DDCPs. Lead regulatory activities across the Vectura Group to support product approvals and ensure alignment with corporate goals.
  • Submission & Compliance: Contribute to the regulatory strategy and execution of global regulatory submissions in accordance with the Medical Device Directive (MDD) and Medical Device Regulations (MDR). Author and maintain MDR Technical Files, Design Dossiers, and ensure devices comply with national and international regulatory requirements.
  • Cross-Functional Collaboration: Collaborate effectively with teams in regulatory, quality assurance, and device engineering to ensure seamless regulatory support and compliance throughout product development and commercialization.
  • Product Development Support: Provide regulatory guidance for new product evaluations and ongoing device development activities, including risk management, human factors, biocompatibility, and clinical evaluations. Assist in the creation of Instructions for Use (IFU) and labels.
  • 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.
  • Regulatory Documentation: Prepare and submit regulatory documentation, including communication with regulatory authorities and notified bodies. Ensure successful collaboration for Notified Body opinions and submissions related to DDCPs and drug-device constituent parts.
  • Technical Documentation & Maintenance: Maintain and archive technical documentation and regulatory files, including the regular review and updates required to ensure ongoing compliance with current standards and legal requirements.
  • Change Impact Assessments: Perform impact assessments on planned changes to medical devices, documenting regulatory impacts through assessment checklists and overseeing any necessary updates to regulatory files.
  • Project Leadership: Lead and support strategic regulatory projects such as the implementation of EUDAMED, UKCA marking, Quality System Management Reviews (QSMR), and the development of new devices.
  • Clinical & Commercial Strategy: Contribute to the regulatory strategy for clinical trial and commercial activities, ensuring alignment with local legislation, language requirements, and registration protocols.
  • Verification & Validation Support: Assist in the planning, implementation, and documentation of verification and validation activities for device development projects.
  • Regulatory Newsletter & Intelligence: Contribute to Vectura's Regulatory Newsletter and provide insights on relevant regulatory updates.
  • 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:
  • Proven experience in Regulatory Affairs, particularly in medical devices and drug-device combination products (DDCPs).
  • 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.
  • Strong attention to detail, problem-solving, and regulatory intelligence capabilities.
Why Vectura?

At Vectura, you'll join a team of innovators working at the forefront of medical technology, where your contributions will directly impact patient care. We offer a dynamic work environment, opportunities for professional development, and a collaborative culture dedicated to achieving excellence.

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