We are looking for a highly motivated Regulatory Affairs Specialist who is expert in medical devices.
What you will do?
Preparation for internal and external auditing, participation in project meetings.
Project DHF management, communication with key people of the project.
Ensure that the project works according to the company’s procedures and work instructions.
Providing inputs of quality and regulation throughout the product development stages.
Registration of the products and actions related to certification,
Communicate with regulatory bodies in different countries, provide various documents, etc.
Impact assessment as a result of a change in the design of the product.
Project support, DHF management and QA&RA documents.
Support for tool and jig development and DHF management.
Support for production projects.
Work on internal organizational procedures, updating and improving.
What do you need to have?
Bachelor’s degree Priority for engineering degree.
Experience in RA required.
Familiarity with standards and guidelines related to medical product development.
Familiarity with processes of quality and compliance with procedures and requirements of medical product development.
Experience in QA&RA – an advantage.
Experience in Medical Advantage.
Auditors Certification for performing an audit advantage.
High level English, reading and writing speech.
Good interpersonal communication.
Ability to work together.
Ability to work on multiple projects.
Commitment to project tasks and times.