MDR_Regulatory Affairs / quality specialist consultant_ MD and MDSW

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 of at least 4years in the following areas:

• MDR 2017/745, MDCGs
• Medical device, medical device software
• ISO 13485, ISO 14971, IEC 62304 - development and implementation of QMS, RA and MDSW specific documents.
• Experience in verification and validation processes, including biolocompatibility product evaluation.
• Establishment of regulatory strategies. Evaluation and classification of products.
• Development of TDs, for submission to NB. Adaptation of documentation according to NBs requirements and available manufacturer's information.
• Support in the elaboration of CEP, CDP and CER.
• Knowledge in the review of documents required for clinical research applications

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.

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