Description
My client, a market leader within the medical devices area is currently seeking a senior quality/regulatory consultant for a long term remediation project.Requirements:
- Higher Education in Engineering or related fields
- Min 5 years experience in Medical Device
- Proven knowledge regarding EU MDD and Quality System Regulations
- Knowledge of regulation and standards including ISO 13485, 21 CFR 820
- Strong experience with DFMEAs and PFMEAs
- Fluent English, additional German is a plus
- EU25/EFTA citizenship
You will be responsible for the remediation of the existing quality/regulatory documentation within the quality/regulatory and R&D department (e.g. technical documentation, risk files, validation reports). Furthermore, you have to perform GAP analyses and the corrective actions afterwards.
If this role could be of interest for you, feel free to send you CV in Word to Marcus Müller at Real Staffing.
<p>To find out more about Real please visit <a href="http://www.realstaffing.com">www.realstaffing.com</a></p>