Perfect Details for the Proper Regulatory Affairs Now

Perfect Details for the Proper Regulatory Affairs Now

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 placing on the market
  • Make recommendations to the different departments to ensure professional ethics
  • Participate in the choice of registration strategies for the product portfolio of the company

Drafting and monitoring of regulatory files:

  • Ensure product access to the market by taking the necessary regulatory steps: obtaining, modifying and maintaining marketing authorizations
  • Collect, from the R & D departments, tests and trials and production, the various types of technical documentation in order to constitute the regulatory files
  • Animate preparation meetings for all registration dossiers
  • Write registration and marketing authorization dossiers and file them with regulatory authorities
  • Track registration files and registration processes with ministries

Variability of activities

The activities of the Regulatory Affairs Consultant differ according to whether he or she is practicing in a company, a firm or a regulatory body.

In business, he intervenes more upstream of the commercial policy with the sales and marketing teams. It is …

Read More