QM Associate - Regulatory Affairs

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 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 Dr. Langer Medical medical devices 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
• Partitipation 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

Requirements

• Degree in (medical) engineering or life sciences preferred, but other degrees may be considered
• Knowledge and experience of medical device regulations such as EN ISO 13485 and MDR (2017/745) as well as FDA 21 CFR part 820 (QSR) and MDSAP
• Professional experience in regulatory affairs or regulatory compliance in the medical device field. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)
• Excellent English and proficient German written and verbal communication skills
• Ability to communicate with all stakeholders
• Independent, structured and pragmatic working style
• Persuasive power