Overview
Medical Device Site Auditors / Product Reviewers Jobs in Ljubljana, Slovenia at Notice d.o.o. (NB 3121)
Title: Medical Device Site Auditors / Product Reviewers
Company: Notice d.o.o. (NB 3121)
Location: Ljubljana, Slovenia
At Notice we are recruiting for Medical Device Site Auditors, Active Medical Device Product Reviewers & Non-Active Medical Device Product Reviewers (EU MDR).
We are particularly interested in experts authorized or eligible for authorization under the following codes:
For Site Auditors- MDT Codes: MDT 2001, MDT 2003, MDT 2004, MDT 2005, MDT 2007, MDT 2009, MDT 2010, MDT 2012, MDT 2013
For Active Product Reviewers- MDA Codes: MDA 0302, MDA 0204, MDA 0302, MDA 0306, MDA 0307, MDA 0308, MDA 0312
(esp. ventilators, infusion pumps, surgical lasers, retinal cameras, electrosurgical instruments, BP monitors, spirometers)
For Non- Active Product Reviewers- MDN Codes: MDN 1101 , MDN 1102, MDN 1103 , MDN 1104 , MDN 1201 , MDN 1202, MDN 1203, MDN 1204 , MDN 1206, MDN 1208, MDN 1209, MDN 1211 , MDN 1213 (esp. cardiac and vascular implants including valves, grafts and stents; dental implants and non-implantable dental materials; surgical meshes and soft-tissue implants; intraocular and contact lenses; ophthalmic solutions and surgical instruments; respiratory masks and gas administration tubes including endotracheal and tracheostomy tubes; wound closure devices such as sutures and staples; adhesion barriers and cystic solutions; dermal fillers and other implantable devices)
For Product Reviewers for Devices with Specific Characteristic MDS Codes: MDS 1001, MDS 1008, MDS 1005 (EO, Moist Heat, Radiation and Aseptic sterilization)
Role Overview
Site Auditors
- Conduct QMS audits under EU MDR
- Assess manufacturing and supplier compliance
- Prepare audit reports and findings
- Collaborate with technical reviewers and decision makers
Product Reviewers
- Perform EU MDR technical documentation assessments
- Participate in conformity assessment activities
- Work closely with clinical experts and internal teams
Education Requirement
- At least a B.Sc. degree in Engineering, Medicine, Pharmacy, Pharmaceuticals, Biochemistry
Competency Requirements
- Minimum 4 years professional experience in medical devices or related sector
- Quality management experience (for auditors)
- Technology/device-specific experience within relevant code
- OR
- Participation in conformity assessments / multiple technical documentation reviews
- For sterilization (MDS 1005): experience in EO, moist heat, radiation, aseptic processes or cleanroom auditing is required.
