UDEM Atlantic is seeking an experienced Internal Auditor to join our team! Applications can be sent through our Linkedin general application linked below.

Linkedin General Application

Company Overview: 

UDEM Atlantic is the United States representative of UDEM Notified Body 2922, a certification body with 25 years of experience in conformity assessment and certification services. Our company issues this certification to medical device manufacturers after auditing their product to ensure it meets compliance and regulatory standards under current legislation in Europe. 

UDEM operates offices worldwide, and is authorized to provide certification in multiple fields, most notably MDR 2017/745 (a Medical Device Regulation certification). We are one of 52 certification bodies worldwide authorized to issue MDR certificates, and have recently opened an office in Massachusetts to offer this service clients in the United States.

Role Overview: 

This is a full-time hybrid role located in Boston, MA with some work-from-home flexibility. As a 2017/745 MDR Auditor, the primary responsibility is to audit and ensure compliance with the Medical Device Regulation (MDR) 2017/745. Daily tasks include evaluating technical documentation, conducting on-site inspections and audits, preparing audit reports, and providing guidance to clients on regulatory requirements and best practices.

Qualifications:

- Experience with Medical Device Regulation (MDR) 2017/745 and related standards

- Skills in technical documentation evaluation and audit preparation

- Familiarity with conducting on-site inspections and regulatory audits

- Strong written and verbal communication skills

- Ability to work independently and in a team environment

- Bachelor's degree in a relevant field such as Biomedical Engineering, Regulatory Affairs, or a related discipline

- Certification in regulatory auditing or related field is a plus