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Sherbrooke

    Regulatory Affairs Specialist - Sherbrooke, Canada - bioMérieux

    bioMérieux
    bioMérieux Sherbrooke, Canada

    3 weeks ago

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    Description

    Primary Purpose and Overall Objective of the Job:

    Develop regulatory strategy of similar and new products and execute regulatory processes as planned.

    Main Accountabilities:

    • Conduct research on regulatory changes and developments and on application requirements and process,
    • Assist in the development and review of procedures,
    • Advise responsible personnel on regulatory requirements and develop options with recommendations; develop product regulatory strategy; assess continuously project output and impact on regulatory strategy and launch date,
    • Validate product labels, instructions for use, advertising and promotional materials,
    • Compile and organize content of regulatory applications and files; assess acceptability and completeness of documents; identify unmet needs and provide feedback; ensure filing and timely retrieval
    • Interact with regulatory authorities and execute regulatory processes; provide feedback on application review progress and questions; coordinate and review answers to questions; report on issues.

    Studies-Experience:

    • Master's degree in Engineering or Life Science
      • Software Engineering or Microbiology preferred
    • Knowledge of regulatory requirements, guidance documents and processes (local/regional) with more than 5 years of practice in the field of IVD/MD in an international environment,
      • Experience with ISO 13485, ISO 14791, ISO 27001 or ISO 27002 are highly preferred
      • Experience with FDA and/or Health Canada preferred
    • Regulatory knowledge : Strong understanding of regulations and standards such as FDA, EMA, (EU) MDR EU2017/745, IVDR EU2017/746, ISO 13485, HIPAA and RGPD.
    • Familiar with local regulatory agency organization,