Regulatory Affairs Strategist for Medical Device Compliance
4 days ago
X4 Life Sciences is seeking a skilled Regulatory Affairs Manager to join their team in London. This role offers a unique opportunity to contribute to the growth and success of a start-up medical device company.
Responsibilities:- Oversee the preparation and maintenance of technical files, dossiers, and regulatory documents to ensure compliance with EU regulations.
- Collaborate with Notified Bodies to obtain FDA and FDR approval for Class 1 Measuring Devices.
- Provide expert guidance on regulatory matters, ensuring adherence to EU standards and assisting in third-party audits.
- Develop and implement EU regulatory strategies to ensure products meet required specifications.
- Manage project assignments for investigational, new, and marketed products, ensuring timely completion and accuracy.
- Liaise with government agencies to gather regulatory intelligence and stay up-to-date with industry developments.
- A minimum of 7 years of experience in regulatory affairs, preferably in a medical device business.
- Thorough knowledge of MDR, ISO13485, and UK MDR regulations.
- Experience interacting with Notified/Approved Bodies is essential.
- Prior experience within orthopedics or surgical devices is highly desirable.
The successful candidate will have the opportunity to work in a dynamic environment, contributing to the development of innovative medical devices. Our company values expertise, creativity, and collaboration, offering a stimulating work atmosphere that fosters professional growth.
Estimated Salary: £80,000 - £110,000 per annum, depending on experience.
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