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Verified by our engine · Posted 7h ago

QM Associate – Product Registrations (part-time 50%) New

Brainlab · Quality Management

Munich

Part-time

Last seen 6h ago

Posted: 7h ago
Workplace: Hybrid
Salary: Not disclosed
Visa sponsorship: Not specified

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At the forefront of health technology for over 35 years, Munich-based Brainlab digitizes medical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.

Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.

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

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