50503MKP - MDR Regulatory Affairs / Quality Specilist consultant_MD and MDSW. Post Doc .(CMG MEDDEV)

This offer is part of the Talent Marketplace organized by Barcelona Activa in collaboration with CATALONIA.HEALTH during the CONNECTION DAY on April 29th. The company CMG MEDDEV needs to fill the vacancy of: MDR Regulatory Affairs / Quality Specialist consultant_MD and MDSW. Post Doc.

Only people who meet the requirements requested by the company will be notified. Attendance and details will be confirmed via email.

Once pre-selected, your availability will be required for the Talent Marketplace: Tuesday 29th April, from 15:00 to 18:30.

• Location to be determined.

FUNCTIONS AND TASKS:

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.

• Type of professional relationship: Contracting

Contract Details:

Type of contract: Permanent

Number of hours per week: 40h

Schedule: 8:00 to 17:00 work online 100%

Gross annual salary: 40,000 € / b / year negotiable according to value.

FORMAL TRAINING:

Graduate or Post Doc in Health Sciences.

TRAINING COMPLEMENTARY:

• MDR 2017 / 745, MDCGs
• ISO 13485, ISO 14971, IEC 62304, ISO 10993 - development and implementation of QMS, RA and MDSW specific documents.
• Experience in verification and validation processes, including biocompatibility 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.
• EXPERIENCE: 6 years in consulting.
• LANGUAGES: Very advanced English.
• COMPETENCIES: Communication skills, proactive, high degree of autonomy.
• REQUIREMENTS: Availability to travel as needed in the national territory and occasionally in the EU.