QM Associate - Regulatory Affairs at Brainlab Inc

Munich, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

20 Jul, 26

Salary

0.0

Posted On

21 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, Medical devices, Technical documentation, Regulatory strategy, FDA submissions, 510(k), Regulatory audits, Quality management, R&D collaboration, Communication, Persuasion, Compliance

Industry

Medical Equipment Manufacturing

Description

Company Description 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 2400 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 You are interested in Regulatory Affairs or in the development of medical devices? As QM Associate in our Regulatory Affairs team you will interact with Brainlab departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Brainlab products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects. Your duties include: Review Technical documentation before CE marking a new/changed medical device Evaluate and follow up design changes during the development and implementation Discuss regulatory topics with R&D colleagues and other departments Support global regulatory strategies for Brainlab medical devices in collaboration with local partners in our subsidiaries Support regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, the Notified Body and other authorities Monitor & investigate regulatory requirements in pre-defined countries Participate in regulatory audits and follow up improvement opportunities Review marketing material Support the release of third party devices Train Brainlab employees in regulatory requirements Qualifications Degree in engineering or life sciences preferred, but other degrees may be considered Professional experience in regulatory affairs or regulatory compliance in the medical device field is an advantage. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D) Excellent English written and verbal communication skills Ability to communicate with all stakeholders Persuasive power 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 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 Department: Quality Management

Responsibilities

The QM Associate will manage regulatory strategies, review technical documentation for medical devices, and coordinate submissions to regulatory bodies like the FDA. They will also collaborate with R&D departments, monitor regulatory requirements, and participate in audits to ensure compliance.