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Our client is a global provider of blood and plasma supplies and services is looking for Regulatory Affairs Manager. This is a permanent role and based in Munich, Germany
Regulatory Affairs Manager (m/w/d)
Accountable to drive and complete all regulatory submission and compliance requirements for a specific product line, business unit or region. Initiates, develops and implements all phases of regulatory strategy to ensure necessary approvals
· Manage the Regulatory Strategy for IVDD and IVDR compliance for the range of our products
· Assist in the implementation of the market approval strategy for other targeted regions/countries (e.g. US and Japan)
· Assist customers/distributors in addressing regulatory issues with respect to product licensing as needed
· Develop and maintain technical files for compliance to applicable regulations
· Ensure compliance with Health Authorities regulations and function as a contact for the Authorities as needed
· Interact with regulatory agency personnel in order to expedite approval of applications, and responses to questions. Responsible for responding to
requests from distributors and/or Regulatory Agencies on new submissions or renewal of submissions
· Provide training and regulatory guidance to company staff. Provide guidance to regulatory and quality staff in the management of requirements and
documentation related to local regulations.
· Review proposed design and/or labeling changes to ensure regulatory compliance
· Work with the Quality organization to determine reportability for product complaints
· Communicate and direct activities pertaining to FSCA (Field Safety Corrective Actions) and FSN (Field Safety Notices).
· Participate in clinical trial design and monitoring
· Develop and track metrics for department performance
· Very good working knowledge of IVD requirements.
· Demonstrated understanding of CE Tech File and is intimately familiar with IVD directive and upcoming regulations.
· Proven experience in creating and maintaining technical files (general IVD and list A for IVDD and has already performed gap assessments for IVDR)
· Good understanding of US registration requirements and clinical trial practices
· Fluent in German and English
· More than 8 years of experience in similar position
· Scientific education with a Master’s degree
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