Quality / Clinical Evaluation Specialist
Location: Munich, Germany
Sector: Medical Devices/Clinical Evaluation/QM/RA
Employment: Full-time or part-time position
Salary: €60,000 - €80,000
You will be a member of the Quality Management and Regulatory Affairs (QM/RA) team as a "Quality / Clinical Evaluation Specialist." You'll work with teams responsible for the development, clinical management, and application development of our clients' cutting-edge biomedical imaging devices. Your efforts will ensure that their items have continual market access. You will communicate with regulatory authorities such as the US FDA or our EU notified body in this job, as well as provide critical input into the development of our clients' products.
Our client provides cutting-edge photonic molecular imaging technology. Their company has had a lot of success since it was launched more than a decade ago. They're working together to advance unique optoacoustic imaging technology for use in preclinical and clinical environments. They have a large number of international customers in a variety of industries.
The following are examples of specific activities:
- Reporting and follow-up on incidents.
- Clinical elements of communication with regulatory agencies.
- Creation of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), post-market clinical follow-up plans.
- Creation of post-market surveillance plans, Periodic Safety Update reports.
- Good knowledge of medical device related regulatory requirements (ISO 13485, CFR, IEC 62304, ISO 14971, etc.).
- Excellent skills in general office SW, basic SW programming skills appreciated.
- Structured and self-motivated way of working.
- Excellent proven communication skills.
- A “hands-on” and “can-do” attitude.
- A passion for exploring new ground, developing a new business, and working closely in a team.
- At least 2 years related work experience in Regulatory Affairs.
- Fluent English.
- Bachelor or master’s degree in engineering or life science.
- Breakthrough technology in the growing medical device sector
- Significant individual responsibility and the ability to actualize own ideas in an interesting and diverse work environment
- Working with a young, dynamic, multinational, and adventurous team
- 30 days holiday
- The option to get shares in the company