Vigilance Manager
Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. 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:
Job Description
Despite our goal to achieve greatest possible reliability and quality in our devices innovative products can fail. As Vigilance Manager you will be responsible to collect and evaluate reports of risks associated with Brainlab’s medical devices and initiate the necessary measures, including fulfilling reporting obligations to local authorities for Serious Incidents and Field Safety Corrective Actions.
Your responsibilities will be to
- evaluate assigned complaints to determine whether the event represents a Serious Incident that has to be reported to local authorities
- manage investigation of potential safety-critical product problems together with technical experts
- conclude on necessary Field Safety Corrective Actions together with General Management
- initiate and manage implementation of Field Safety Corrective Actions, including communication of safety-critical problems to affected customers via Field Safety Notice
- submit reports related to medical device risks to authorities according to FDA 21 CFR 803 and 806, EU MDR 2017/745 and other applicable requirements worldwide
Qualifications
- Degree in engineering, medicine or life sciences
- Professional experience in medical device industry
- Knowledge of global Medical Device Vigilance Regulations is a plus
- High level of reliability and sense of responsibility
- Very strong attention to detail, as well as a structured and analytical approach
- Persuasive power and critical thinking abilities
- Excellent documentation practice and communication skills in English language
- Proficient in the use of MS Office
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
- 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.
