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Lead Regulatory Affairs Specialist

Regulatory & Quality Assurance
230 Total Views
In this role you will manage the development, implementation, and maintenance of Regulatory strategies, Brexit registrations, submissions, and activities related to manufacturing activities in Manchester.

Your Key Accountabilities:

  • Interpret and apply regulations by creating regulatory strategies for the Manchester production facility
  • Provide regulatory support to divisional diagnostic RA and the EMEA region
  • Define, monitor, collate, and publish deliverables for submissions in coordination with divisional Diagnostic RA e.g. translation, registration, labeling, PEO requirements
  • Interact with regulatory agencies and support submission projects directly impacting the Manchester site
  • Participate in Material Review Board (MRB) for Manchester manufactured product, performing regulatory approval of Non-Conformances, Corrective Actions, Preventative Actions and Change Orders (e.g. ECOs/SCOs)
  • Review and approve Equipment Change Controls (ECCs) impacting Manchester product or processes
  • Participate in Product Quality Committee (PQC) and complaint/recall/field action meetings
  • Support new product launch activities and attend Core Team meetings
  • Represent RA in Management Review by preparing and presenting data
  • Participate on manufacturing transfer teams as regulatory representative
  • Manage all product registrations within the MHRA registration portal and perform updates/amendments as required
  • Support audit and re-certification activities
  • Assess and approve labeling, process, and procedures changes for regulatory impact and ensure maintenance of regulatory compliance
  • Support product registration and tender activities by providing relevant regulatory documentation (e.g., DoC, Labels, Certificates, Packaging, Certificates of Free Sale)
  • Advise and guide management and other personnel in other departments on the interpretation and application of regulations
  • Maintain knowledge of current and proposed regulations, laws, guidelines standards, and initiatives impacting the Manchester production facility.  Assess impact and disseminate throughout the organization for continued regulatory compliance
  • Own/create/update local regulatory procedures/templates and co-ordinate training to relevant personnel
  • Communicate developments in Brexit and act as appointed UK representative
Your Knowledge, Skills and Experience:

  • Must have advanced knowledge of applicable regulations and standards e.g. ISO 13485, ISO 14971, CFR 820 Part 21, MDSAP, 93/42/EEC, 98/79/EC, 2017/745 and 2017/746.
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations.
  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Must demonstrate initiative, balanced assertiveness working as a team player.
  • Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
  • Ability to manage multiple projects

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