The Role:Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds (early development, late development, marketed) for the WE Area...
REGULATORY AFFAIRS MANAGER / ASSOCIATE / PROFESSIONAL - MEDICAL DEVICES - NOTTINGHAM - PERM £COMP
A family owned medical device company based in Nottingham are seeking an experienced Regulatory Affairs Associate to join their team. They manufacture their own in-house developed products alongside taking on projects to manufacture externally developed medical devices.
Reporting to the director of quality and regulatory affairs, you will be the lead advisor on all regulatory matters within the business so strong communication skills are key.
Main Duties;Plans, prepares and co-ordinates the development of pre-market applications and related submissions to Notified Bodies, FDA and other regulatory agencies.Create, maintain and control technical documentation (STeD, Technical File) to support registration activities.Develop and execute plans to ensure compliance of regulatory documentation to new Medical Device Regulation 2017/745Support the maintenance and control of design history filesSupport the business through new product development and the product lifecycle on regulatory matters Liaise with production, logistics, customers and competent bodies
In order to deliver in this position it is ideal that you have experience of ISO 13485. You will be expected to work to you own initiative, prioritise your workload and be proactive.
Apply today- / 07490217352 / 0161 868 2236
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.