Quality Assurance
vor 2 Wochen
**Quality Assurance & Regulatory Affairs (QA/RA) Manager - Medical Devices**
ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.
With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.
We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.
**About the job**:
To strengthen our team in Basel, we are looking for a Quality Assurance & Regulatory Affairs (QA/RA) Manager in Medical Devices.
**Quality Assurance**:
- Act as the liaison with external parties on matters relating to the quality system that include regulatory/client and third-party audits.
- Management Representative, responsible for implementation, governance, performance reporting.
- Ensure compliance to applicable regulatory requirements (MDR, ISO 13485, US FDA).
- Support R&D with development and maintenance of the technical files according to applicable regulatory requirements.
- Act as Site Management
- Representative and coordinate all audits, inclusive of schedules, communication, reports and tracking follow-up actions.
**Regulatory Affairs**:
- Develops regulatory strategy for new products (Class I and II).
- Manages compliance to all relevant regulations, rules and standards for products and taking part in the conformity assessment procedures with coordination of all concerned departments.
- Accompanying development projects, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentations.
- Elaborates and reviews changes to existing Products, SOPs, Test Methods,
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies.
- Lead regulatory assessment of marketing claims and external communication.
**Leadership Activities**:
- Lead others in the completion of project tasks and sub projects
- Smooth & facilitate the decision-making process.
**Requirements**:
- Master's degree in life science, engineering or related fields.
- Five (5) years minimum experience in regulatory affairs in MedTech.
- Current knowledge of Medical Device Regulation (MDR 2017/745), ISO 13485 etc.
- You are an Excellent team player in a multicultural environment.
- Self-starter with ability to work independently under pressure and react quickly to changing priorities.
- You are comfortable with decision process and decision making.
Type d'emploi : Temps plein
Programmation:
- Travail en journée
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