Senior Regulatory Affairs Specialist

LausanneFixe2018-07-10Master / Université
Our Client, an international Medical Device company is looking for a:

Senior Regulatory Affairs Specialist

Your Responsibilities

Purpose of the Role:
Support major Pre and Post Market activities related to Company Products
Assists the Regulatory Affairs Manager in every matter and help administer the company regulatory program in accordance with regulatory requirements and company profile.
Assists the Regulatory Affairs Manager for Post-marketing activities like Vigilance, Reportable Event and Product Recall.
The Senior Regulatory Affairs Specialist will be in charge to manage for his/her dedicated product line, engineering changes, regulatory compliance, vigilance, recall, risk management file and post-market surveillance.

Main Responsibilities
Medical Device Regulation (MDR) Project Manager
Promotes / communicates awareness of regulatory requirements throughout the organization
Manage QA/RA key projects within the company
Keeps information regarding standards and regulations concerning medical devices and their manufacturers up-to-date together with the Regulatory Affairs Manager
Coordinates Post Market activities such as complaints, vigilance reporting and resulting actions for injector families
Supports maintenance of Technical Files such EC technical Files, 510(k) for his/her dedicated product line
Support maintenance of Risk Management File with Risk Management Coordinator for his/her dedicated product line
Coordinates and executes standards surveillance for all Products and act as web tool administrator on the related platform.
Participates during notified body audit and other inspections
Establishes procedures for maintaining compliance with regulatory standards

Qualifications

Engineering or University degree preferably in a field that offers as opportunity to gain all-around background.
5+ years of previous experience in a medical device or pharmaceutical environment
Knowledge in management of complex QA/RA Projects
Good communication and strong interpersonal skills
Very good knowledge of MS Office
High personal commitment
Able to work independently and flexible to change priorities
Fluent in English and French language both written and oral, other European language skills are an asset

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -072018-292921

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