We have an exciting opportunity for a QA/RA Manager to join the team. The client is an established leader in the Medical Device market and operates globally.
Responsibilities:
- Main point of contact for notified bodies
- Experience managing global regulatory submissions
- Regulatory consultant in the launch of new products
- Maintenance of European Regulatory Compliance
- Supporting Registration Support and Regulation Assessment.
- Revision of technical documentation, creation of various documents and creation of risk analyses
- Research change procedures
- Post-market Surveillance
Requirements:
- 4+ years in Regulatory Affairs (Medical Devices)
- Experience with QMS
- Strong knowledge of the normative and regulatory requirements for medical devices (ISO 13485: 2016, ISO 14971: 2019, Directive 93/42 / EEC and Regulation (EU) 2017/745 (MDR)
- Strong Communication Skills
- Strong Project Management skills in the QA/RA Space
- Strong managements skills, working with different departments
- Excellent command of English and ideally German proficiency
- IT Proficiency
