Title:  Sr. / Director, Regulatory Affairs






  • Excellent analytical abilities, strong communication skills in order to collaborate with colleagues and interface with suppliers and customers as needed.
  • Effective attention to detail in order to successfully oversee regulatory initiatives.
  • A minimum of 10 years of device design and development experience.
  • Minimum of 10 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  • Bachelor's degree in relevant field





  • A strong knowledge of domestic and international regulations.
  • Master’s in business or scientific discipline.


Skills & Competencies:


  • Excellent analytical abilities, strong communication skills, and effective attention to detail
  • Strong leadership and interpersonal skills.
  • Ability to develop personnel through mentoring and coaching, both formally and informally, and most importantly by example.
  • Versed at developing metrics and implementing actions that make improvements in those metrics.
  • Experience in developing and conducting presentations with Power Point





  • Leads the Regulatory department and acts as the face of Enable in interactions with partners and regulatory authorities.
  • Directs the workload and oversees the output of a team of regulatory professionals.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Prepare or direct the preparation of master files and technical files as necessary to obtain and sustain product approval.
  • Ensure compliance with regulations.
  • Outlining requirements for labelling, storage, and packaging.
  • Writing comprehensible, user-friendly, clear finished product artwork and labels.
  • Oversees post-market work to ensure products remain in compliance once on the market.

Nearest Major Market: Cincinnati