FDA Inspector

Summary

Join RQM+, a MedTech CRO, as an Ex-FDA Inspector to conduct FDA mock audits for clients in the EU and U.S. This contract position involves a mix of on-site and remote audits. You will leverage your experience as a Medical Device Inspector for the US Food & Drug Administration (FDA) to plan and execute audits, issue reports, and mentor clients. The role requires strong communication, collaboration, and the ability to navigate challenging situations with diplomacy. RQM+ offers an industry-leading compensation package and a focus on work-life balance. Apply if you're interested in learning more and beginning your journey with us.

Requirements

• The candidate will have previously worked as a Medical Device Inspector for the US Food & Drug Administration (FDA), within the past 10 years (2015-2025) and with a minimum of 5 years’ experience as an Inspector
• A former US FDA Medical Device Inspector (within the past 10 years, 2015-2025) with a minimum of 5 years’ experience as an FDA Inspector
• Expertise in Quality System Inspection Technique (QSIT)
• Robust auditing experience
• Communicate effectively and proactively
• A university degree or equivalent in science or nursing

Responsibilities

• The candidate will be expected to travel globally to conduct onsite audits
• The candidate will work with the RQM+ project team to coordinate the audit schedule
• The candidate will work with the RQM+ project team to support the audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report
• The candidate will be capable of providing the clients with 80% auditor (hats on) and 20% mentor (hats off)
• The candidate will be responsible for identifying opportunities where RQM+ can provide additional support and assistance to the client. These opportunities shall be fed back to the RQM+ project team
• The candidate will be responsible for maintaining their training in new / revised regulations, standards and guidance’s as they become available
• This is a client facing role and the candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits
• As an auditor there will be challenging situations and difficult conversations with the client
• When appropriate the candidate will escalate the challenging situation to the RQM+ project team
• The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right

Preferred Qualifications

• Expertise in ISO13485:2016, MDSAP audit techniques highly desirable
• Expertise in EU MDR / EU IVDR audit techniques an advantage

Benefits

From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals