Regulatory Affairs Manager

Regulatory Affairs Manager
  • £50,000 - £60,000 per Annum
    ANNUM
  • Permanent
  • England, UK UK CH2 4NU
Job Ref: J2162863
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 17 January 2022
MDD to MDR project, work autonomously to ensure innovative class II portfolio is in line with new regulations. 100% remote, or work from NW or...

Leading biocides company, innovating, developing, and marketing medical devices across a range of sectors, including human, lab, dental and veterinary.

As Regulatory Affairs Manager, you will lead all aspects of their medical device programme, to ensure their MDD to MDR transition, including reviewing design and development documentation and authoring product regulatory and quality documentation.

This role can be 100% remote based - you would be welcome to work from sites in either the South East, or North West.

RESPONSIBILITIES

  • Act as the person responsible for Regulatory Compliance in accordance with the Medical Device Regulations, EU 2017/745
  • Registration of Medical Devices within territories of sale including UK, and EU
  • Compliance of all medical Devices placed on the market with relevant national/regional regulations
  • Generation/Maintenance of technical documentation including: Technical Files, Risk Analysis, Clinical Evaluation, Post Market Surveillance
  • Liaison with Notified body and Competent Authority
  • Alignment of regulatory documentation, and processes with the QMS system
  • NPD input throughout the development process

SKILLS AND EXPERIENCE

  • BSc or equivalent in a scientific discipline, medicine, pharmacy, law or engineering relevant to medical devices and professional experience in QARA
  • Or, four years of professional experience in QARA management systems relating to Medical Devices (documented qualification)
  • Proven knowledge, practical implementation and management of all regulations that affect the placing of Medical Devices on the market
  • Experience of undertaking Clinical evaluation, risk management (ISO14971) and post market surveillance activities.
  • Knowledge of ISO13485
  • Proven track record of preparation and/or registering Medical Devices in UK/European and/or other international markets
  • Technical knowledge to be able to liaise effectively with chemists, microbiologists, and virologists
  • Good communication skills to translate complex regulations and scenarios to different audiences (interview)For more information, or to discuss your career in Regulatory Affairs/Quality Assurance within the Med Tech space, please contact Holly Evans, on holly.evans@srgtalent.com

SRGTalent
16/02/2022 09:39:54
GBP 50000 60000 Annum
Contact Consultant:
Holly Evans

Submitting application, please wait..

Share location?

Do you want to share your location for better user experience ?