Regulatory Affairs Consultant
A Parisian Clinical Research firm is currently searching for a Regulatory Affairs Consultant to work in the UK, providing regulatory support for clinical investigations. The organisation specialises in the regulation and clinical development of new medical technologies. This is the ideal opportunity for a candidate who's looking to positively contribute to the development of medicine.
- To act as project manager for all regulatory aspects of a medical device clinical study, throughout the duration of the study, reporting directly to sponsors and managing internal resources.
- To draft regulatory documentation for submission to competent authorities, ethics committees and other bodies for pre-market and post market clinical investigations with medical devices.
- To advise on European and national requirements and other regulatory issues relevant to clinical investigations with medical devices.
- Acting as regulatory representative at meetings with business partners and regulatory agencies.
- Ensures compliance with regulatory agency regulations and interpretations.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope and complexity.
Skills and Requirements
- Graduated with a degree in a scientific field (e.g. Biomedical Engineer, Pharmacist or Scientist).
- Ideally, at least two years post-graduate experience in the conduct, management or evaluation of clinical trials or with the development or regulation of healthcare products in the European market, of which at least one year of direct relevance to European medical device regulation.
- Knowledge of pre and post-market regulatory requirements and processes for medical devices in Europe.
- Knowledge of the regulatory requirements, principles and processes applicable to clinical investigations or pre-clinical research for Medical Devices (e.g. ISO 14155, GCP, ISO 14971)
- Expertise in a relevant specialist area relevant to medical devices would be an advantage.
- Excellent written and verbal communication skills
- Fluent English is mandatory, and another European language would be desirable, particularly Italian or Spanish.
- The ability to build and maintain excellent working relations with clients and colleagues
- Take initiative and work independently with minimal direct supervision and to organize heavy workloads effectively, successfully managing multiple tasks with competing demands, conflicting priorities and tight deadlines.
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 0203 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.