Regulatory Affairs Manager

• Participate on project development teams to ensure that appropriate regulatory strategies are communicated, and regulatory requirements are met
• Take care of the preparation and editing of the technical and formal documentation necessary to get registrations and keep them in compliance with product changes with a particular focus on the international Area
• Manage premarketing, maintenance and renewal regulatory activities for the manufacturing site in the international Region, in collaboration with the regional regulatory team
• Cooperate in the relationships with Vigilance Authorities, Competent Authorities and the National Government Agencies in Europe and in the International Area.
• Distribute appropriate notifications for product approvals and report on the status of approvals to appropriate company functions
• Monitor, verify and review product documentation (Instructions for use, brochures, Company website, etc.) to ensure compliance with relevant law requirements
• Interface/correspond with government agencies, industry organizations, distributors, and international personnel to keep abreast of regulatory requirements
• Provide necessary/requested information and materials to government agencies, distributors, and international personnel to meet regulatory requirements
• Assist if required during facility audits/assessments by government agencies
• Keep up to a high level of knowledge and comprehension of laws and regulations impacting on Company products

Minimum Qualifications

• Technical Scientific University degree
• RAPS Society RAC designation is a plus
• 5+ years’ experience in the field of regulatory affairs; product conformity obtained, at least in part, in Companies in the Medical Device sector.
• Knowledge of standards and regulations related to medical devices in EU and US (EUMDR, ISO 13485, 21
  
  CFR
  820) as well as in the international area
• Knowledge of the fundamentals of SAMD, digital health or AI regulations
• Ability and experience in preparation of technical and formal documentation necessary for submission and assessment at Notified Bodies and/or Competent Authorities.
• Preparation of organizational procedures