Auditor Consultant- Ex-FDA Experience

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

With over 500 team members globally, providing world-class consulting services in a remote capacity is nothing new for RQM+. We are dedicated to the highest levels of client service and employee satisfaction delivered with empathy, integrity, individual pride and company spirit.

To help support our ever growing and expanding Global Audit Practice, we’re interested in speaking to Auditors who would be interested in supporting RQM on various supplier/vendor audits on a contract basis for our clients in the EU and U.S. These will be a mixture of on-site and remote desktop audits.

We’re interested in speaking to Auditors with a background in any of the following fields:

· ISO 13485:2016

· EU MDR

· 21 CFR 820

· 21 CFR Part 4

· 21 CFR Part 11

· Quality System Gap analysis

· Mergers & Acquisition Audits

· Mock FDA Inspection

· MDSAP

· IVD

· EU IVDR

· ISO 9001:2015

· ISO 17025

· ISO 14971

· ISO 60601

· ISO 62366

· ISO 62304

· ISO 10993

· Sterilisation

· Pre-Clinical

· Clinical

· ICH Q7 Requirements

· ICH Q10 Requirements

· 21 CFR 210/211

Being an industry leader in client support is just the beginning for RQM+. Providing a rewarding place to work is rooted deep in the core values of RQM+. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment. At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today! 

We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us. 

We require willingness to work a flexible schedule and travel at least 25% of the time