As the successful candidate in this role, you will be a part of the UL Medical Regulatory Team, responsible for auditing some of the most regulated products in the world. Working with limited supervision, you will independently assist and support auditing and processing of manufacturer submissions to the ISO13485, the Medical Device Singe Audit program, and the In Vitro Diagnostic Directive (IVDD) and, where applicable, other regulatory requirements.
Additionally, you will be responsible for:
- Identify and manage priorities as demonstrated by the ability to establish, track, and meet schedules for multiple projects while maintaining project quality.
- Have a strong customer focus, flexibility
- Demonstrate a confident, calm and decisive personality
- Perform audits at the customer site lasting anywhere from 2 to 10 business days.
- Perform contract review / project planning for technical file/design dossier evaluations and quality management system audits.
- Assess technical file/design dossier and quality management systems against European Directives, essential requirements and latest common technical specifications.
- Support regular quality system and technical audits, including unannounced audits.
- Subject to training and qualification milestones, perform key CE certification responsibilities to support safe products to market.
- Have competent working knowledge of ISO 13485 and relevant medical device directive (MDD) and invitro diagnostic devices directive (IVDD).
- Participate in development and delivery of training materials to UL assessors.
- Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
- Provide guidance and support to customers as required. Participate in client training and customer forums.
- Overseas travel is expected