Regulatory Affairs Project Manager – Medical Devices
MedPass International is a consulting firm specialising in the regulation and clinical development of new medical technologies. Founded in 1991 and located in Paris, MedPass International provides a full range of customised regulatory/reimbursement consulting and CRO services to medical device manufacturers seeking to place and maintain their products on the European market.
For our Department of Regulatory Affairs, we are looking for a Regulatory Affairs Associate/Consultant to work in the areas of regulatory support for clinical investigations.
- 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 provide advice on European and national requirements and other regulatory issues relevant to clinical investigations with medical devices.
- Scientifically/technically qualified at least to degree level in an appropriate subject (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 at all levels, to take the initiative and work independently with minimal direct supervision and to organise heavy workloads effectively, successfully managing multiple tasks with competing demands, conflicting priorities and tight deadlines.
This is a permanent position, based at our head office in Paris. We may also consider applications of candidates based in UK or Germany.
If you are interested in this career opportunity, please send your curriculum vitae to firstname.lastname@example.org.
Further information about MedPass International is available from our website: www.medpass.org