Medical Device Compliance Manager
2 weeks ago
Vectura Group Overview:
We strive to deliver innovative solutions in inhaled medicines and medical devices, prioritizing quality and compliance to benefit patients globally.
Job Summary:
This role requires an experienced professional to lead our regulatory affairs efforts, ensuring the success and timeliness of medical device submissions. The successful candidate will contribute to the development of our regulatory strategy and facilitate global compliance.
Main Responsibilities:
* Develop and implement regulatory strategies for medical devices.
* Manage relationships with regulatory authorities and notified bodies, ensuring compliance with relevant standards and legal requirements.
* Oversee key regulatory projects, including EUDAMED implementation, QSMR, UKCA compliance, and development devices.
* Provide guidance on regulatory requirements and standards related to drug delivery.
* Support the development of risk management documentation, DHF maintenance, and the creation of IFUs and labels.
* Collaborate with cross-functional teams to ensure compliance with language requirements, local legislation, and registrations.
* Identify and analyse the impact of new or revised standards and legal requirements.
* Contribute to the company's Regulatory Newsletter as needed.
Required Skills and Qualifications:
* 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.
Benefits:
* Competitive salary and benefits package
* Opportunities for career growth and development
* Collaborative and dynamic work environment
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