Senior Regulatory Affairs Specialist

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.

Responsibilities

• 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.