The FDA Group is seeking regulatory consultants trained and certified to audit against the Medical Device Single Audit Program (MDSAP) and ISO 13485:2016.

Apply your experience with The FDA Group, a global leader in GxP auditing, remediation, and staff augmentation.


The FDA Group engages pharmaceutical, medical device, and biologic companies around the world and is seeking quality and compliance professionals who are trained and certified to audit against MDSAP and ISO 13485:2016.The FDA Group engages pharmaceutical, medical device, and biologic companies around the world and is seeking quality and compliance professionals to support medical device companies transitioning to MDSAP and ISO 13485:2016. 

We are looking for experienced professionals with the skills, knowledge, training and, preferably, certification to assess quality systems against MDSAP and/or ISO 13485:2016. 

Key tasks include:

  • Gap Analysis:Evaluate current quality management systems to determine level of compliance with ISO 13485:2016 and/or MDSAP and develop quality plan with action items needed to bring system into compliance.

  • Pre-Assessment Auditing: Perform preparatory assessment audits prior to Notified Body or Registrar certification audit. Duties may also include conducting on-site ISO 13485:2016 and/or MDSAP training for key employees to ensure ongoing compliance.

As a consultant with The FDA Group, you will provide provide clients with expert recommendations and/or take an active role in bringing their processes and procedures into compliance with 13485:2016 and/or MDSAP.

If you are interested in taking advantage of this consulting opportunity, please send the information listed below to info@thefdagroup.com.

  • First name
  • Last name
  • Phone number
  • A brief summary of your professional experience
  • Cover letter (Word doc)
  • CV (Word doc)