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Regulatory Affairs Manager

Personnel Futures Ltd
Job LocationHockley
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

SummaryTo ensure the appropriate licensing, marketing and legal compliance of the Medical and Scientific portfolio. This role represents a key position within the RAQA 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. This includes both locally manufactured devices intended to be marketed globally, especially in MDSAP markets and the wider portfolio marketed in the region.Results

  • 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.
    • 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 to Subject matter experts within and key stakeholders.
  • Generate RA registration plans for new product developments, product changes and renewals.
  • Maintain technical information related to the summary of technical documentation (STED), such as Declarations of Conformity (DofC), Device Master Records (DMRs) and any other which may be required as part of CE certification and registration activities.
  • Support and supply information as required relating to Product Registration in any market where products marketed, especially MDSAP markets, including site /establishment registrations and product registrations, such as FDA 510(k) and EU CE Marking.
  • Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations.
  • Attend and support Design review activity and generate the required regulatory documentation for product certification purposes.

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