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Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Canton
Posted on: November 26, 2022

Job Description:

Responsibilities:


  • Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
  • Assist in keeping company informed of regulatory requirements in the US and EU.
  • Participate on Product Development teams by providing regulatory strategy, timelines, and direction.
  • Prepare US and EU submissions. Work with Notified Body and FDA to obtain product approval/clearance. Ensure relevant ISO and FDA requirements are met, as required.
  • Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures.
  • Review labeling, training, promotional and advertising material.
  • Support post market regulatory compliance activities for US/EU product approvals.
  • Develop and maintain regulatory affairs department procedures and process improvements.
  • Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
  • Assist in keeping company informed of regulatory requirements in the US and EU.

    Requirements:


    • 5+ years of US/EU medical device regulatory submission experience with Bachelor's degree
    • 510(k) or PMA submission experience
    • Knowledge of FDA and EU requirements
    • Strong communication skills
    • Strong technical writing skills
    • Regulatory Affairs Certification
    • Master's degree in Regulatory Affairs or Engineering
    • PMA experience
    • IDE experience

Keywords: Katalyst Healthcares & Life Sciences, Boston , Regulatory Affairs Specialist, Other , Canton, Massachusetts

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