Regulatory Affairs Specialist - Southend-on-Sea, United Kingdom - Olympus KeyMed Group Companies

Olympus KeyMed Group Companies
Olympus KeyMed Group Companies
Verified Company
Southend-on-Sea, United Kingdom

2 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Responsibilities:


We are recruiting for a Regulatory Affairs Specialist to join our Regulatory team, on a fixed term contract to cover maternity leave.

In this role, your duties will include the development and review of product technical documentation such as medical device files and all related documents to demonstrate regulatory compliance to the Notified Body as well as regulatory dossiers required for submissions of registrations to the competent authorities where the company intends to market their products.


  • Maintain technical information related to the summary of technical documentation (STED), such as Declarations of Conformity (DofC), Device Master Records (DMRs) and any other which may be required as part of CE certification, UKCA and registration activities
  • Manage Engineering Change Request/ Engineering Change Order (ECR/ECO) process including notifications of changes which are notifiable under local regulations
  • Drive Regulatory Affairs procedural updates, as needed, in collaboration with cross functional inputs
  • Support new product development
  • Execute international product registrations according to individual country specific requirements
  • Registration of Olympus portfolio with MHRA and support activities for compliance to UK regulations
  • Review of promotional materials
Your qualification

  • Experience in regulatory affairs, quality or R&D in the medical device industry
  • Good understanding of the regulatory framework applicable to medical devices
  • Ability to interpret legislative text
  • Excellent communication and negotiation skills
  • Good organisational skills
  • Ability to work in a team
Your competencies

  • Integrity
  • Empathy
  • Long-Term View
  • Agility
  • Unity
Your benefits

  • Generous annual leave entitlement
  • Comprehensive company pension scheme
  • Private medical cover
  • Free annual health check
  • Subsidised gym membership
  • Employee discounts
More jobs from Olympus KeyMed Group Companies
See all jobs of Olympus KeyMed Group Companies