Regulatory Affairs Specialist - 6mth FTC - Southern

Medical/Pharmaceutical - Regulatory
Ref: 443 Date Posted: Friday 10 Sep 2021
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Summary of post:

 To support local registration activities as well as post-market surveillance activities related to reporting of product adverse events (PAE) to competent Authorities.

Key Result Areas:

  • Product registration support: provide the necessary technical documentation and notarised/legalised documentation to regional S-BCs to support them in the registration activities required for submissions to the Competent Authorities where our client intends to market their products.
  • Post-Market Surveillance: ensure continued compliance to all relevant regulatory requirements regarding timely reporting of product adverse events (PAE) to Competent Authorities.

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 product registration purposes.
  • Report adverse events in a timely manner to Competent Authorities when applicable.
  • Manage and implement Field Safety Corrective Actions and provide feedback to Competent Authorities where required.
  • Manage Engineering Change Request (ECR/ECO) process including notification to S-BCs of changes which are notifiable under regulations.

Other Related Duties:

  • Liaise with internal and external resources to ensure timely delivery.
  • Participate in Continuous Improvement activities
  • Undertake any assignment or duty as required by business needs.
  • Training of internal stakeholders and other RAQA resources.
  • Creation and maintenance of Standard Operating Procedures (SOPs).
  • Meet both internal lead times and regulatory timelines for reporting PAE (initial MIRs, follow-up MIRs and final MIRs as required).
  • Where required, act as RA back-up for reporting and completion of FSN/FSCA.

Qualifications & Experience:

  • University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering or equivalent experience.
  • Minimum of 1 year of experience in regulatory affairs, quality or R&D in the medical device or pharmaceutical industry in product registration, medical device file and/or technical compliance activities.
  • Good understanding of EU MDD/MDR, ISO 13485 requirements and ability to communicate these technical and regulatory documents to a less specialist audience.
  • Knowledge of medical devices, post-market surveillance, quality compliance.
  • Sound IT skills in Ms Office (Ms Word, Ms Excel, Ms Power Point).


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