Job Description
As a Product Assessor, you will play a crucial role in our organization by overseeing Sterilization product assessments and conducting technical file reviews in strict adherence to regulatory requirements, including the European Medical Device Directive and Medical Device Regulation for Class IIa/IIb and/or Class III. Your primary focus will be to ensure the technical soundness of reviews and compliance with all relevant standards.
Responsibilities:
1. Conduct comprehensive Sterilization product assessments in line with regulatory requirements for medical devices.
2. Support CE marking activities conducted by SGS, contributing to the overall certification process.
3. Effectively communicate with colleagues and clients regarding product assessments and related activities.
4. Work proactively to minimize risks associated with medical device certifications.
Qualifications
5. A degree or equivalent qualification with Microbiology modules or relevant studies (, medicine, pharmacy, engineering, or other related sciences).
6. Four years industrial experience with medical device manufacturing that includes at least two years of experience in the operation of the relevant sterilization processes, particularly in following methods (MDS1005/ MDS1011)
7. In-depth knowledge of sterilization processes including ETO, Irradiation, Steam/Moist heat, Aseptic, Hydrogen Peroxide and other sterilization methods
8. In-depth knowledge of clean room/environmental controls and validation processes .
9. In depth knowledge of shelf-life studies and validation for sterile devices.
10. Familiarity with non-active, non-implantable devices for disinfection, cleaning, and rinsing, as well as solutions for disinfecting medical devices. (MDN1211)
11. Previous experience conducting Sterilization Product Assessments for a Certification/Notified body is highly advantageous.
12. Professional English