Heyer Regulatory Solutions LLC



The expert source for global regulatory strategies.


Boston Scientific Corporation:        Vice President, Global Regulatory Affairs

Medical Device Consultants, Inc:    Director, Global Regulatory Services

Food and Drug Administration:       Scientific Reviewer, Surgery, Orthopedic and Restorative

                                                       Devices Branches



  • Multiple successful PMA approvals for Class III medical devices in the US, most recently for a device used during coronary bypass surgery.  The PMA was approved within 9 months from the submission of the last PMA module.


  • More than 100 cleared 510(k) submissions including 510(k)s with clinical data and substantial software documentation.  A recent 510(k) for a new software monitoring system used during cardiac surgery cleared with one round of minor questions.


  • A track record of productive meetings with FDA reviewers across CDRH. Excellent relationship with premarket and postmarket FDA staff.


  • Managed US and foreign clinical studies from start to finish - strategy and planning, recruiting investigators, qualifying investigational sites, writing clinical study documentation, working with CROs for study monitoring and management, data analysis, report writing, and presentation to regulatory authorities.
  • Experience with global submissions in a variety of geographies including EU, Canada and Japan. 
  • Implemented regulatory and compliance systems to improve product and process quality including a regulatory submission quality control process, regulatory submission tracking database, product incident review process for potential field action/recall, complaint handling and MDR/vigilence reporting process.
  • Delivered training on a variety of regulatory and compliance topics, including global regulatory submissions, changes in the FDA 510(k) program, clinical study requirements, postmarket surveillance, medical device advertising and promotion issues, MDRs, recalls, design and process controls, and risk management.


  • Completed several regulatory and compliance due diligence projects for major medical device acquisitions and leveraged buy-outs.