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About Vectura Group:
We are a global leader in the development and delivery of inhaled medicines and medical devices. Our mission is to innovate, ensure quality, and maintain compliance in delivering effective treatments for patients worldwide.
Job Overview:
We are seeking an experienced professional to join our regulatory affairs team, contributing to the successful and timely approval of relevant medical device submissions. This role will ensure global regulatory compliance while supporting our corporate goals.
Key Responsibilities:
* Contribute to the regulatory strategy and global approval process for medical devices.
* Prepare final regulatory documentation and manage communications with regulatory authorities and notified bodies.
* Lead or support key regulatory projects, including EUDAMED implementation, QSMR, UKCA compliance, and development devices.
* Maintain and archive device registrations while ensuring compliance with relevant standards and legal requirements.
* Support development activities, including risk management documentation, DHF maintenance, and the creation of IFUs and labels.
* Develop regulatory strategies for clinical trials and commercial activities, ensuring compliance with language requirements, local legislation, and registrations.
* Assist regulatory affairs for medicinal products in the submission of drug-device combination products, either in collaboration with partners/customers or for internal proprietary programs.
* Identify and analyse the impact of new or revised standards and legal requirements.
* Contribute to the company's Regulatory Newsletter as needed.
* Assist in the planning, execution, and documentation of verification and validation activities.
* Serve as the Deputy of the Associate Director as appropriate.
Education & Experience Requirements:
* Significant experience in medical device regulatory affairs, including industry and/or regulatory agency/notified body experience.
* Strong understanding and ability to interpret medical device regulations and guidelines, including CFRs, MDD, ISO 13485, EN 60601-1, EN 14971, and EU MDR.
* In-depth knowledge of medical device regulatory guidelines and standards related to drug delivery.
* A relevant university degree (engineering, life sciences, or equivalent) OR approximately 5 years of professional experience in regulatory affairs or quality management systems related to medical devices.
* Experience engaging with Regulatory Authorities (e.g., FDA, Notified Bodies).
* Strong ability to work independently, manage multiple projects, and meet deadlines.
Why Choose Vectura?
* Be part of an innovative science-driven company making a meaningful impact in healthcare.
* Collaborate with experts in regulatory affairs, quality assurance, and device engineering.
* Work on cutting-edge medical devices and combination products.
* Enjoy a competitive salary, benefits, and career development opportunities.
