Senior RAQA Consultant

England Permanent Remote View Job Description
We are seeking a Senior RAQA Consultant with significant experience in Regulatory Affairs/Quality within SaMD/AIaMD. This role will work with a portfolio of medical device manufacturers so the successful candidate will be working with a varied portfolio of devices and stages.
  • Fantastic opportunity to consult on RAQA strategies
  • Fantastic opportunity to join a rapidly growing Medical Device Consultancy

About Our Client

Our client is a rapidly growing medical device consultancy in the UK focused on Software and AI devices. They are committed to supporting clients with regulatory and market access and providing exceptional consultancy services to its clients.

Job Description

  • Guide and implement regulatory & quality strategies for product development and marketing
  • Monitor, evaluate, and interpret all applicable regulatory rules, ensuring that they are communicated through policies and procedures
  • Submission of technical files to the applicable markets
  • Advise on subjects such as premarket regulatory requirements, export and import requirements, or clinical study compliance issues
  • Coordinate efforts associated with the preparation of regulatory documents or submissions
  • Provide regulatory guidance
  • Prepare and maintain regulatory submissions and databases
  • QMS Implementation / Training

The Successful Applicant

A successful Senior RAQA Consultant should have:

  • A background in Life Sciences or a related field
  • Proven experience as a Regulatory Affairs & Quality professional within a medical device manufacturer or similar role
  • Knowledge of legal and regulatory requirements within Software / AI as a medical device
  • Strong attention to detail and ability to work effectively under pressure
  • Excellent written and verbal communication skills

What's on Offer

  • The opportunity to work fully remotely
  • A vibrant and diverse work culture
  • Competitive benefits package
Contact
Kelly Percival
Quote job ref
JN-012025-6640380
Phone number
+44 1727 730 143

Job summary

Job function
Life Sciences
Subsector
Regulatory Affairs
Sector
Healthcare / Pharmaceutical
Location
England
Contract type
Permanent
Consultant name
Kelly Percival
Consultant phone
+44 1727 730 143
Job reference
JN-012025-6640380
Job Nature
Remote