Regulatory Affairs Manager - Permanent - Essex - Southern

Medical/Pharmaceutical - Regulatory
Ref: 398 Date Posted: Tuesday 13 Oct 2020
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Our client is looking for a Regulatory Affairs Manager 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,  and the wider portfolio marketed in the UI region where our client acts as a 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

Principle 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 the company 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 our client markets its products, 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

Other related duties:

  • Participate in Continuous Improvement activities
  • Undertake any assignment or duty as required by business needs.
  • Adequacy and regular review of Technical File /Risk Management in accordance with current regulations.
  • Maintenance and compliance with Standard Operating Procedures (SOPs) related to Quality Management System as well as Health, Safety and Environment.
  • When required, provide assessment of reportability of product adverse events (PAE) and provide support for completion of reporting and completion of field safety notices and actions (FSN/FSCA)

Qualifications & Experience:

  • University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience.
  • Minimum of 5 to 10 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, FDA QSR, JPAL, MDSAP requirements and other key international regulations 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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