BostonRecruiter Since 2001
the smart solution for Boston jobs

Regulatory Affairs Specialist

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

Job Description:


  • 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.


    • 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds