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
Qualifications
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
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
Regular team, and company events
Internal company fitness program
Comprehensive training and continuing education opportunities offered by Brainlab
TOP 100 innovator and employer of the future 2022
Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.
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