Senior Regulatory Affairs Specialist
- Deputise for the Regulatory Affairs Manager, within a global medical device organisation
- NPD focused work, with a focus on EU, UK and US
- Cheshire Location, with flexibility on remote working
About the company
SRG partner with a North West based Medical Device Leader, approaching a period of expansion. As Senior Regulatory Affairs Specialist, you will deputise for the RA Manager, with a key focus on new product development across a robust product area.
- Creation, and maintenance of high quality regulatory compliant documentation across all classes of products
- Drive regulatory processes such as Change Control, GMDN ect.
- Ensure Pre-market clearances are achieved in a timely manner
- New product development - liaison with project development teams across R&D, Marketing, Sales and Operations
- Ensure timescales and regulatory pathways are fully understood, communication to the wider team, and planned accordingly.
- Prepare the pre-marketing documentation for all regions as designated e.g. for CE marking and 510k according to the agreed timeline
- Development and maintenance of relationships with relevant regulatory bodies, both from an NPD and post market perspective
Skills and Experience
- Regulatory/Quality experience within the medical device arena
- New Product development experience for medical devices
- Experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
- Experience with US 510K would be preferable
- Experience of medical device digital, MD software MD Apps would be advantageous
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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