Quality & Regulatory Affairs Specialist - Medical Devices

2019-05-02 14:21:042020-04-12Helix Medical Recruitment
Job Type Permanent Full Time
Location High Wycombe, Buckinghamshire
Area South Central, UK & IrelandLondon, UK & IrelandHome Counties, UK & Ireland High Wycombe, Buckinghamshire
Sector HealthcareHealthcare - EngineeringHealthcare - Other
Salary £28,000 - £35,000 + great benefits
Start Date ASAP
Advertiser Healthcare Team
Telephone 01323 44 54 54
Job Ref JR846.088
Description

As Quality & Regulatory Affairs Specialist for this established medical device company you'll be based from the High Wycombe area.
 

  • Working in a small, talented team as Quality & Regulatory Affairs Specialist, you'll cover day to day management of the technical documentation review process for technical files, creating files in accordance with ISO 13485 regulatory standards for medical devices.
  • Support medical device new product development, investigate and manage technical enquiries and customer complaints, train others on quality management systems (QMS), and more in this varied Quality & Regulatory Affairs Specialist role.
  • Based close to High Wycombe, the office is commutable from Maidenhead, Slough, Bracknell, Hayes, Uxbridge, Amersham, Watford, Hemel Hempstead, Aylesbury, etc.


COMPANY

  • A well-established and award-winning medical device company ensuring significant improvements to patients' quality of life by providing quality products and outstanding customer care. The company provides excellent employee training and ongoing development opportunities.


REQUIREMENTS

  • Experience in a similar Quality & Regulatory Affairs role working with medical devices or pharmaceuticals to ISO 13485 regulatory standards. You must have experience in creating / maintaining technical files in accordance with MDD / MDR.
  • A degree in a Life Science, Pharmaceutical or Engineering discipline, clear communications skills and a team player keen to learn and develop as a Quality & Regulatory Affairs Specialist.


PACKAGE

  • Salary of £28-35,000 plus great benefits.


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