Reg Affiars Specialist - Product Registration - Essex - Southern

Medical/Pharmaceutical - Regulatory
Ref: 406 Date Posted: Tuesday 24 Nov 2020
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Role Summary:

Our client is looking for a Regulatory Affairs Specialist to ensure the appropriate licensing, marketing, and legal compliance of their Medical and Scientific portfolio. This role represents a key position within the RA/QA organisation since they need to act as liaison between R&D, Business Development, Product Management and other RA/QA representatives to ensure both new product developments and current portfolio meet the regulatory requirements for all regions where they are the legal manufacturer. This includes both locally manufactured devices intended to be marketed globally, especially in MDSAP markets and the wider portfolio marketed in the UI region where our client acts as distributor. 

Key Result Areas:

  • Ensuring continued compliance with all relevant regulatory requirements of both internal corporate standards and external regulations and standards issued by Competent Authorities, Notified Bodies and Certification Bodies. This role acts as company representative when required for communications with Competent Authorities, Notified Bodies and Certification Bodies.
  • Timely identification and co-ordination of regulatory changes to ensure no negative impact on the business. This includes 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
  • Post-Market Surveillance: ensure continued compliance to all relevant regulatory requirements regarding timely reporting of product adverse events to Competent Authorities. Co-ordination of Field Safety Corrective Actions (FSCA) both for products where our client acts as legal manufacturer and distributor and communications with internal stakeholders, and any requests raised by the Competent Authorities and Notified Bodies as a result of those actions.

Principle Responsibilities:

  • Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
  • Support and generate updated technical documentation for Medical Device File.
  • Manage Engineering Change Request (ECR/ECO) process where regulatory actions are required including notification of changes, translations, and any other regulatory actions which are notifiable under regulations.
  • Manage and implement Field Safety Corrective Actions and provide feedback to Competent Authorities where required.

Other related duties:

  • Liaise with internal and external resources, Competent Authorities and Notified Bodies to ensure timely delivery.
  • Participate in Continuous Improvement activities
  • Undertake any assignment or duty as required by business needs.
  • Adequate and regular review of Medical Device File/Risk Management in accordance with current regulations.
  • Provide training in RA and FSCA processes of internal stakeholders, Subject Matter Experts and other RAQA resources.
  • Maintenance of Standard Operating Procedures (SOPs).
  • Meet internal lead times for completion of FSCA.
  • Meet reporting timelines to Competent Authorities for adverse event reporting and completion of FSCA.

Qualifications & Experience:

  • University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering or equivalent experience.
  • Minimum of 3 to 5 years post qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file and/or technical compliance activities.
  • Good understanding of EU MDD/MDR, ISO 13485 and MDSAP requirements and ability to communicate and provide training on these technical and regulatory documents to a less specialist audience.
  • Knowledge from a registration perspective of active medical devices, risk assessment, clinical experience, post-market surveillance, quality compliance.
  • Sound IT skills in Ms Office (Ms Word, Ms Excel, Ms Power Point).

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