The Regulatory Affairs Consultant implements the company’s technical and regulatory strategy to ensure the application of regulations for the development, marketing and distribution of health products. It performs all activities related to registration, marketing authorizations (MA) or CE marking, registration in exporting countries.

With the current regulatory framework increasingly complex and rapidly changing, many companies choose to outsource companies to carry the regulatory issues of Medical Devices and quality assurance tasks as a way to ensure compliance.

Main activities:

• Definition and implementation of a regulatory strategy
• Confer with the research teams, the marketing and quality department, in order to comprehend the distinctiveness of the developed product
• Describe a regulatory strategy consistent with the commercial policy and R & D of the company
• Provide operational support to all internal departments to guarantee the proper application of quality protocols, in a permanent effort to comply with the quality and safety requirements for

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