QM Associate – Product Registrations (part-time 20hweek)
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Job Summary
At Brainlab we develop innovative medical devices to make an impact for healthcare providers physicians and their patients. As a QM Associate Product Registrations you will be part of the international Regulatory Affairs team overseeing and managing medical device approvals around the world. Your goal is the worldwide registration of the Brainlab medical devices in correspondence with regulatory authorities (e.g. Health Canada Australian TGA) in order to make our technology available to hospitals and patients around the world.
Your responsibilities are to
- prepare regulatory submissions of medical devices to health authorities
- support local partners in the preparation of regulatory submissions
- monitor and implement laws and regulations that impact product registrations
- keep regulatory databases up-to-date
- support the maintenance and improvement of the product registration processes
- participate in and support internal and external quality audits
Qualifications :
- Degree in engineering or life sciences preferred but other degrees may be considered
- Interest in quality management and regulatory affairs
- Knowledge of international regulations for medical devices is an advantage
- Ability to manage multiple projects
- Very strong attention to detail
- Proficient in the use of MS Office
- Excellent communication skills in English; Other languages are an advantage
Additional Information :
- A mutually-supportive international team
- Meaningful work with a lasting impact on medical technology
- 30 vacation days plus December 24th and December 31st
- Flexible working hours as well as hybrid work model within Germany
- Bike leasing via cooperation partner BikeLeasing
- Parking garage and safe underground bike storage
- Award-winning subsidized company restaurant and in-house cafes
- Variety-rich fitness program in our ultra-modern 360m2 company gym
- Regular after work team and company events
- Comprehensive training and continuing education opportunities
Ready to apply We look forward to receiving your online application including your first available start date and desired salary.
Contact person: Ayline Föll
Remote Work :
No
Employment Type :
Part-time
About Company
Brainlab revolutionized digital medical technology with the introduction of software for radiosurgery and surgical navigation. Today, Brainlab is an industry leader in digital surgery, radiotherapy and integrated operating rooms.Serving physicians, medical professionals and patients i ... View more
