In the role as Manager (m/w/d) Regulatory Affairs you are leading the RA department of BRAHMS GmbH (Hennigsdorf). You are setting the direction for achieving added value and securing/maintaining compliance to international regulations by implementing and executing regulatory processes throughout all different departments according to international standards and regulations (e.g. ISO 13485, MDSAP, 21 CFR 820).
What will you do?
- Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of products‘ registration.
- Establish and lead all aspects of regulatory strategy including successfully handling global regulatory submission projects, such that they integrate with the overall objectives of the program they support.
- Ensure that Regulatory Affairs (RA) teams globally are accountable for delivering on agreed strategies and tactics.
- Participate in product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
- Lead resources to ensure each project/core teams have appropriate regulatory support, mentorship, and resources to develop regulatory strategies and timelines.
- Responsible for the planning and implementation of all regulatory activities in the product life cycle in coordination with the Director RA/QA
- Implement, follow and continuously improve various RA processes according to international standards and regulations (e.g. ISO 13485, 21 CFR 820, MDSAP, GMP)
- Take an active part in all audits to fully represent the regulatory section