IVDR_Regulatory Affairs / quality specialist consultant_ ISO 15189 and IVD

What are we looking for?

We are looking for a graduate or post doc, who is enthusiastic, involved, with organizational skills and a strong commitment to teamwork.

With demonstrable knowledge and experience no less than 4 years in the following areas:

• ISO 15189, ISO 14971, ISO 17025 and valuable IEC 62304 and ISO 13485- development and implementation of QMS, RA and MDSW specific documents.
• IVDR 2017/746, MDCGs.
• Thorough knowledge of any or all of the following techniques: NGS, Molecular and Immunohistochemical technologies.
• Expertise in the validation of all or some of the above techniques.
• Valuable knowledge to develop TDs.
• Valuable knowledge to develop PEP, PER (included scientific, analytical and clinical evaluation), PMPF.

What we offer

• Permanent contract, salary according to the employee's skills and competence and the requirements of the position.
• Team attendance at congresses and learning forums.
• Continuous training.
• Working in an organization of 10 employees, close, with direct relationship with the CEO, a person of recognized prestige and knowledge in the sector; and working in a team.
• 100% remote working mode. The company provides you with the necessary tools for its development.
• Pleasant working environment.

Responsibilities

• Be autonomous in the leadership and execution of projects to obtain CE marking of products.
• Report weekly to your superior on the progress of the projects.
• Establish the most suitable regulatory strategy for the customer.
• Development of the customer's QMS documents and support in their implementation.
• Development with the client of the TD of the product.
• Interactions with ON.
• Periodic meetings with client for the progress of each project and for the resolution of doubts or explanation of concepts.
• Development of web publications related to technical aspects of your position.
• Development of presentations for congresses.