Essential duties and responsibilities:
- Obtain and maintain international approvals for medical devices
- Know the most current registration and maintenance requirements for international markets
- Provide support to and advise R&D in the interpretation of regulatory requirements
- Communicate new statutory registration requirements to R&D and brand management and provide support with the implementation thereof
- Ensure that regulatory requirements for the registration of medical devices in the product development process are met
- Supervise product managers during the entire product life cycle from a regulatory perspective and ensure that the technical product documentation is compliant with the regulatory requirements for medical devices
- Assess all products of the R&D department with respect to their risk potential
- Assume responsibility for the regulatory content of product-related information and its release
- Implement conformity assessment procedures for products and initiate the creation of the Declaration of Conformity
- Approve medical devices for market release
- Provide support in the preparation and conduct of audits
- Be an active member in the product development teams.
Qualifications:
- Degree in science or engineering, medical degree, or relevant industry experience
- Three years’ experience in Regulatory Affairs and experience in international product registration, possibly in the field of medical devices or in the pharmaceutical industry. Experience in quality management and product development is a plus
- Knowledge of (EU) 2017/745 (MDR: product classification, applicable standards) and further specified requirements
- Experience to successfully collaborate with interdisciplinary teams
- Exceptional knowledge of MS office; experience in document management or ERP Systems (i.e. SAP) is an advantage