Job DescriptionAs 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:Conduct comprehensive Sterilization product assessments in line with regulatory requirements.Perform meticulous technical file reviews for Class IIa/IIb and/or Class III medical devices.Support CE marking activities conducted by SGS, contributing to the overall certification process.Provide guidance and assistance in training and qualifying junior staff members.Develop and create training materials to enhance the skillset of the team.Effectively communicate with internal team members and clients regarding product assessments and related activities.Work proactively to minimize risks associated with medical device certifications.QualificationsWe are seeking a candidate with the following qualifications and skills:Extensive experience in medical device manufacturing. Process knowledge is required in following methods (MDS1005/ MDS1011)In-depth knowledge of sterilization processes, including ETO, Irradiation, Steam, Aseptic, etc.Familiarity with clean room controls and validation processes for relevant sterilization methods.Previous experience conducting Sterilization Product Assessments for a Certification/Notified body is highly advantageous.A degree or equivalent qualification with Microbiology modules or relevant studies (, medicine, pharmacy, engineering, or other related sciences).Proficient communication skills, including electronic communication methods.Strong written English skills for the preparation and review of reports.Specific knowledge of medical device/ procedure packs sterilization processes, including methods such as ETO, Irradiation, Steam (and dry), Aseptic, Hydrogen Peroxide (gas plasma), and other sterilization methods.Familiarity with non-active, non-implantable devices for disinfection, cleaning, and rinsing, as well as solutions for disinfecting medical devices and devices manufactured in clean rooms and controlled environments.Join our dynamic team and contribute to the quality and safety of medical devices through your expertise in sterilization product assessments.
