• Permanent Position
  • Bayern
  • Recruiter: Ashwini Shirvaikar

The Life Science Career Network CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes. 

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)

Job Details

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

 

Main responsibilities:

·        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

 

Experience/Skills:

·        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

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.