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