Contract - Regulatory Affairs Manager - Devices - East Midlands
- Employer
- Mosaic Regulatory Solutions
- Location
- East Midlands Airport, Derby (GB)
- Salary
- Flexible
- Start date
- 25 Feb 2021
- Closing date
- 10 Mar 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Contract : 3 to 6 months
Location:East Midlands
Role : Regulatory Affairs Manager - Devices - Must have wearable device experience
You need the following experience:
We seek to appoint a RA/QA Manager, which is an excellent opportunity for an experienced yet ambitious professional to join a fast paced, entrepreneurial culture in a challenging role supporting regulatory compliance across the business.
The RA/QA Manager will have responsibilities for overseeing quality and regulatory activities across the group and as such we are looking for a proactive, experienced professional who can work with and guide our product development team as well as supporting regulatory compliance for the wider group.
The main responsibilities of this role include:
Management of the QMS (Quality Management System)
Responsible for regulatory compliance for MDD, MDR and ISO 13485
Compile technical files for Diagnostic and Drug Delivery devices
Develop, manage and maintain the company’s device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
Direct liaison with Notified Bodies and Regulatory Agencies including FDA and other international agencies
Risk and CAPA management
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Company
Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.
Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.
We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.
Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.
Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.
- Website
- http://www.mosaicreg.co.uk/
- Telephone
- 07951 082482
- Location
-
Blackheath
London
SE3
GB
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