We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further Haemonetics is your employer of choice.
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.
Workplace : Munich
Conditions of Employment : Haemonetics’s requires COVID-19 vaccination for all U.S. employees who work in the presence of other colleagues or customers, unless the employee is approved for a medical or religious exemption, pursuant to applicable law.
While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, customers and communities as we continue to make health and safety our top priority.