Senior RA Executive - Medical Devices

A specialist consultancy company providing global Regulatory Affairs, Pharmacovigilance, and Quality Assurance services is seeking a Senior RA Executive - Medical Devices. Proclinical is partnering with this company to announce the vacancy, which will be located in the company's office in Buckinghamshire. This is an excellent opportunity for a talented, independent, and self-motivated regulatory professional to join a team that will not only provide you with a wide variety of experience in regulatory projects, it will also give you all the support you need to develop your regulatory career.

Job Responsibilities:

• Providing regulatory expertise in the development, registration, and post-approval activities of medical devices.
• Ensuring high quality and timely delivery of consulting services to clients.
• Working directly with clients, handling tasks with minimum supervision, and interacting professionally at multiple levels within client organisations.
• Forging strong relationships with clients and regulatory agencies.
• Participating in a wide variety of medical device projects (class I to III).

Skills and Requirements:

• Life Sciences Graduate or Pharmacist, ideally with a post-graduate qualification.
• 3-4 years of experience in the medical devices field of regulatory affairs.
• Solid knowledge of the medical device Directive/Regulation and MEDDEV guidelines.
• Good regulatory affairs experience, including a successful track record in writing medical device technical files.
• Up-to-date knowledge on the current EU Medical Device Directive and upcoming changes in the Regulation.
• A good working knowledge of ISO 13485 and experience in maintaining a Quality Management System for a medical device portfolio.
• Excellent technical writing skills and confidence of in preparing documents such as clinical evaluation reports, risk management plans, and device labelling.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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