Regulatory Affairs and Compliance Manager

2 weeks ago


London, Greater London, United Kingdom X4 Life Sciences Full time

X4 Life Sciences is seeking a highly skilled Regulatory Affairs Manager to support their growing business in London.

The ideal candidate will have more than 7 years of experience in regulatory affairs, preferably within a Medical device business.

The salary for this role is estimated to be around £90,000 per annum, depending on the individual's qualifications and experience.

Key Responsibilities:
  1. Oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
  2. Provide regulatory guidance and support, ensuring compliance with EU regulations, and assist in third-party audits.
  3. Develop and implement EU regulatory strategies, ensuring products meet all necessary requirements.
  4. Manage project assignments for investigational, new, and marketed products.
  5. Liaise with government agencies and gather regulatory intelligence.
Competencies:
  1. Familiarity with EU regulations and guidelines related to medical devices and pharmaceuticals.
  2. Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information.
  3. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  4. Highly organized and detail-oriented, with the ability to manage multiple projects simultaneously.


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