Regulatory Affairs Specialist

Posted 23 September by Personnel Futures Ltd
Easy Apply

To ensure the appropriate licensing, marketing and legal compliance of BC Medical and Industrial manufactured products

Key Result Areas

  • Ensuring continued compliance to all relevant regulatory and quality requirements
  • Timely identification and co-ordination of QA/RA regulatory changes to ensure no negative impact on the business.
  • Successful completion of mandatory training

Compliance with Health & Safety, QA/RA and Environmental procedures

Responsibilities

  • Liaise with QA/RA management throughout the global organisation to ensure consistent global approach to regulation compliance.
  • Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
  • Ensure current regulations and standards are available.
  • Generate and maintain the DMR/DofC.
  • Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist.
  • Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations.
  • Initial review of complaints to determine and record reportability.
  • Ensure reportable events are reported within timescales as required by all market regulations. Notify senior management as appropriate.
  • Determine whether FSCA is required and generate a Recall File as necessary. Manage all activities and ensure Recall file is regularly updated.
  • Support and supply information as required relating to Product Registration in any market including site /establishment registrations including FDA 510(k), CE Marking etc.

Support Change management process (ECR/ECO) and report changes to S-BCs as appropriate.

Qualifications & Experience

University degree in a scientific / engineering subject. At least five to ten years experience in a regulatory, QA/RA or quality role for a medical device manufacturer. Ability to perform ISO 9001 / 13485 audits and good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.

Reference: 36178832

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