Overview
RA&QA Associate Jobs in Schlieren, Zurich, Switzerland at Polaroid Therapeutics
Title: RA&QA Associate
Company: Polaroid Therapeutics
Location: Schlieren, Zurich, Switzerland
Regulatory Affairs & Quality Assurance Associate (100%)
You will combine the responsibilities of regulatory affairs and quality assurance. Your tasks can be described as follows:
Regulatory Affairs:
- Supporting our development projects of medical devices for wound healing by preparing technical documents
- Support product submission documents for Europe, US, middle east & APAC markets
- Support the preparation of notified body or authority audits
Quality Assurance:
- Maintenance tasks of companies electronic Quality Management System
- Uploading external documents, maintenance of quality register containing approved supplier, change management cases or CAPA/ non-conformity cases
- Updating SOPs, Work Instructions and Records as part of process improvement activities
You should have the following experience:
- Bachelor's or master's degree in manufacturing engineering, biomedical engineering, or natural sciences
- 2 years' experience in Medical Device RA&QA
- Further training and certificates in Medical Device RA&QA are an advantage
- Profound knowledge of ISO 13485 and 14971, 21 CFR Part 820, EU MDR requirements
- Ability to prioritize and to meet deadlines
- Team player with ability to work independently
- Outstanding interpersonal skills in communication, presentation and technical writing
- Proficiency in English (written and spoken), German and/or another language is a plus
