skip to Main Content

Regulatory Affairs Specialist, Cleveland, OH

Support the team in the development and execution of regulatory strategies.

Primary Responsibilities

  • Review routine change orders and product complaints for accuracy, effectiveness, and compliance.
  • Complete regulatory assessments for product and process changes and non-conforming material reports.
  • Support and prepare sections of regulatory submissions, including but not limited to IDEs and 510(k)s.
  • Maintain a database of standards, regulations, and FDA guidance documents.
  • Remain current with new and changing regulatory requirements in US, EU, Canada and ROW, communicate those requirements internally, assess impact on procedures and operations, and implement internal changes as necessary.
  • Ensure compliance with pre- and post-market regulatory requirements, including assessment of product complaint reportability and submission of any Medical Device Reports.
  • Support scheduled and unannounced notified body audits and FDA inspections.

Requirements

  • Bachelor’s Degree in Engineering, Science, or Healthcare related field.
  • Minimum of 2 years of medical device experience including knowledge of related US regulatory requirements OR a Master’s Degree in Regulatory Affairs with 0-2 years of related experience.
  • Must have an understanding of US medical device regulatory requirements.
  • Must be an effective oral and written communicator and be able to lead meetings and clearly present ideas.

Why Join Our Team?

  • Entrepreneurial work environment
  • Small, collaborative office environment
  • Competitive compensation and benefits
  • Employee Wellness Program
Back To Top