Medical Device Expert

3 weeks ago


Keighley, Bradford, United Kingdom Cure Talent Full time
Company Overview

Cure Talent is a leading recruitment agency specializing in the Medical Device sector. Our mission is to provide exceptional candidates to meet the growing demands of our clients.

We are seeking an experienced Senior Regulatory Affairs Associate to support our client's growth and success in the Medical Device sector. The ideal candidate will possess strong technical knowledge and experience in the Medical Device sector.

  • Maintaining regulatory compliance with MDD/MDR standards
  • Creating, reviewing, and updating Technical Files
  • Coordinating post-market surveillance activities
  • Ensuring regulatory compliance with ISO 13485 requirements
Responsibilities and Requirements

The key responsibilities include:

  • Working closely with the Regulatory Affairs Manager to maintain regulatory compliance
  • Creating, reviewing, and updating Technical Files for submission to regulatory bodies
  • Coordinating post-market surveillance activities to ensure product conformity
  • Supporting cross-functional teams for new product launches
Requirements

To be successful in this role, the ideal candidate should possess the following qualifications:

  • Proven experience in the Medical Device Sector within a RA role
  • Strong technical writing and communication skills
  • Ability to analyze data and make informed decisions
  • Knowledge of medical device regulations (MDD/MDR) and ISO 13485
Salary and Benefits

The company offers a competitive salary range of £45,000 - £55,000 per annum, depending on experience. This position provides an excellent opportunity for professional growth and development in a dynamic industry.



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