International Regulatory Affairs Manager - Medical Devices - Gosselies
Our Client is is a medical devices company active in gastro-enterology. The company is dedicated to the development of innovative devices providing new means of therapeutic interventions for gastroenterologists. It is a spin-off from Université libre de Bruxelles, based on a collaboration between the engineers of the engineering school and the gastroenterologists from Erasme Hospital.
The product has been recently CE marked and in order to develop their activities on an international level, they are looking for an International Regulatory Affairs Manager .
You are looking for a professional challenge that allows you to work in a start-up environment in order to develop International Regulatory Affairs activities?
You have acquired experience with international submissions (including FDA) in the medical devices industry and you want to take the lead on Regulatory Affairs Projects for the international market?
Plus One can offer you this great challenge:
Your key responsibilities:
Primary responsibility for all regulatory topics in the USA and other international countries (Bresil, Canada, Australia, India, Japan, etc.)
Contact point with US FDA regarding product vigilance.
Ensures requirements of Quality Management System in full compliance with international regulations.
Serves as liaison with Notified bodies and US FDA and/or consultants on product approval issues.
Prepares and maintains the US and international Regulatory budget.
Prepares and maintains all documentation and procedures related to international submissions
Remedial Actions and Medical Device Reporting.
Assesses advisory notice reporting on an international level.
Develops, review, and/or submit incident reports and field safety corrective action notices to FDA and any other relevant international competent authority as required.
Participates in Health Hazard Evaluations as needed
Stops the manufacture and/or distribution of medical devices should it be determined that the safety, quality, identify of the product or process has been compromised.
Master or PhD in Biomedical Engineering or Sciences
Minimum 5 years’ experience in Regulatory Affairs, including on international projects (FDA)
Demonstrate experience in the application premarket files (and coach someone on the topic)
Demonstrate experience in Gastro-intestinal devices is an asset
Show experience in the application of ISO 9001 & 13485
Show experience in gap assessment between US requirements and foreign requirements (gap with CE mark is a plus)
Show experience in the application of other standards
Show experience in the application of complaint management and product vigilance requirements
Manage large projects
Independently write procedures
Write and speak English fluently
Use standard communication tools (e.g. MS Word, Excel, PowerPoint, e-mail)
Independently write procedures and coach others to use and write them
Efficiently manage data
Our Client offers a full-time permanent position along with an attractive remuneration package.
The position is based in Belgium (2 locations: Gosselies and/or Brussels and with flexibility for homeworking) and has an international scope.
You will be part of a highly skilled and dynamic team headed by a solid management team.
This is an agile start-up company culture focused on values of autonomy, commitment, team-spirit and excellence
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