Regulatory Affairs Specialist
  • Canton, Massachusetts, US
  • +914043515100
415 Days ago
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.

Requirement:

  • 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
Industry
  • NA

Required Skills
  • Regulatory Affairs Specialist

Experience
  • 5 Years of Experience

Salary
  • NA

Working Hours / Week
  • 40h