Clinical affairs manager Jobs in Waldkirch
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Clinical affairs manager • waldkirch
- Gesponsert
QM Consultant - Regulatory Affairs
Dr. Langer Medical GmbHWaldkirch, Württemberg, GermanyRegulatory Affairs Specialist - (m / w / d)
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Dr. Langer Medical GmbHWaldkirch, Württemberg, GermanyCompany Description
Dr. Langer Medical GmbH, based in Waldkirch, Germany, which has been part of Brainlab in Munich since 2022, has specialized in the development and marketing of highly innovative medical technology for intraoperative neuromonitoring and neurostimulation for more than 25 years. Our products are groundbreaking in design and handling and form the basis for our worldwide growth. It is therefore no coincidence that the products from Dr. Langer Medical as well as the company itself have been honored several times in the past with various prizes and awards.
Job Description
You are interested in Regulatory Affairs or in the development of medical devices? As QM Consultant in our Regulatory Affairs team you will interact with Dr. Langer Medical 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 Dr. Langer Medical products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects.
Your duties include :
- Collaboration on the creation, updating and review of the technical documentation before / after CE marking a new / changed medical device
- Evaluate and follow up design changes during the development and implementation
- Participation in the documentation of product changes - change management
- Discuss regulatory topics with R&D colleagues and other departments
- Establish global regulatory strategies for the medical devices of Dr. Langer Medical in collaboration with local partners of the Brainlab subsidiaries
- Compile 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
- Participation and preparation of regulatory audits and follow up improvement opportunities
- Regular market monitoring and preparation of PMS / PSU reports
- Train Dr. Langer Medical employees in regulatory requirements
Qualifications
Additional Information
Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.
Contact person : Géraldine Ferrer