We have an exciting opportunity for a Senior Regulatory Affairs Manager to join the team. The client is an established leader in the Medical Device market and operates globally.
Responsibilities:
- Develop, implement, and manage local and international RA / QA system(s) in respect to the EEA / WW Quality System and applicable standards like ISO 13485.ISO 9001 and IVD regulation together with the Sr. Director RA.
- Develops and supports a positive liaison between the company and regulatory agencies
- Responsible for products registrations and provides support to international product registration processes within EEA.
- Key Person for EUDAMED data base
- Ensures all manufacturing and packaging are in compliance with regulatory and Immucor standards.
- Contributes to the quality oversight of IVD production and oversight of quality release processes of IVD products
- Manage the product risk management and post market monitoring and reporting processes required by regulation.
- Support requirements for change controls
- Serves as point of contact to internal and external partners for quality systems and compliance related topics.
- May initiate, review and approve documentation
- Acts and conducts as lead auditor
- Acts as the quality representative for the all EU affiliate office and works closely together with all affiliates as needed.
- Act as Deputy Person for Regulatory Compliance for technical documentation
Characteristics:
- Bachelor's degree in Science degree
- Strong knowledge of IVDD standards
- Experience of the administration of compliance monitoring and risk management
- Leadership experience
- Native German and Fluent English
- High self-motivation and ability to work independently
