Regulatory Affairs Consultant - Medical Devices

Job Description 

We offer a job as a Regulatory Consultant – Medical Devices, in which you will:

• optimally combine your scientific background and regulatory knowledge
• work in an international environment of pharmaceutical and medical device/in vitro diagnostics industry
• prepare and update technical documentation (eg. PSUR, BSER, CER, RMP) for applications
• coordinate and manage authorisation procedures and interactions with notified bodies
• implement and maintain ISO 13485 QMS perform IVD and medical device directive vs. regulation gap analysis
• be coached by MY CLIENT "professional approach with a personal touch" spirit Profile

Requirements:

• an MSc/PhD in Pharmacy, Medical Biology, Chemistry, Life Sciences
• 2-3 years of experience in the medical device/IVD industry, preferable RA/QA knowledge of ISO standards
• preferably, audit experience
• the eagerness to learn, develop and excel a flexible and pragmatic personality the ability to handle stringent deadlines
• writing and editing skills (English) the ability to communicate in a convincing way