We are looking for an experienced regulatory
affairs professional to work in our Department
of Regulatory Affairs. This is a permanent position,
based either at our head office in Paris or
remotely (with frequent visits to the Paris
office).
Main Responsibilities:
to develop advice to clients in relation to
strategic consultancy projects, major adverse
events and non-compliant situations;
to to manage the work of the MedPass Adverse
Event Surveillance Unit and co-ordinate the
investigation and reporting of adverse events
and corrective action associated with medical
devices in the pre- and post-market phases;
to prepare technical documentation and advice
to clients, Regulatory Affairs Department staff
and other MedPass Departments in relation to
European and national requirements and other
regulatory issues relevant to the conformity
of medical devices with European medical device
regulations;
to draft regulatory documentation for submission
to Competent Authorities, Ethics Committees
and other bodies in relation to to clinical
investigations with medical devices;
Profile:
Demonstrable ability to take the initiative
and work independently with minimal direct supervision,
seeking advice when appropriate and effectively
managing heavy workloads comprising multiple
tasks with competing demands, conflicting priorities
and tight deadlines.
The ability to build and maintain excellent
working relations with clients and colleagues
at all levels
Excellent written and verbal communication skills.
Fluent English is mandatory and another European
language would be desirable.
Scientifically/technically qualified at least
to degree level in an appropriate subject (e.g.
Biomedical Engineer or Scientist).
At least four 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 two years must be of direct
relevance to European medical device regulation
and at least two years of direct relevance to
adverse event management.
Knowledge of pre- and post- market regulatory
requirements and processes for medical devices
in Europe, including familiarity with the principles
and processes applicable to conformity assessment,
risk and quality management, clinical evaluation
and pre-clinical studies (e.g. ISO 13485, ISO
14155, ISO 14971)
Expertise in a specialist area relevant to medical
devices would be an advantage.
Contact information: If you are interested in this career
opportunity, please send your curriculum vitae
to benedictesorrel@medpass.org
We are always looking for staff throughout
Europe such as Project Managers, CRAs…
If you are interested in a career opportunity with
MedPass international, please submit your resume
here:
to develop advice to clients in relation to
strategic consultancy projects, major adverse
events and non-compliant situations;