Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist
  • £55,000 - £65,000 per Annum
    ANNUM
  • Permanent
  • Chester, Cheshire, England, UK Chester Cheshire UK CH5 2NU
Job Ref: J2159526
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 23 March 2021
Deputise for the Regulatory Affairs Manager, within a global medical device organisation

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.

SRGTalent
22/04/2021 13:28:03
GBP 55000.00 65000.00 Annum
Contact Consultant:
Holly Evans

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