Regulatory Affairs Manager

Overview

Our client is a multi-national medical device manufacturer with a broad product line. The role will focus on their Neuromodulation product, which is the only one of its kind on the market. Innovation is at the heart of what they do, and you will be a key driver of this in the role.

• 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
• Prepare organizational procedures

• 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

✉️ If you are interested in this exciting role, please send your application directly to sam

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Please note:

Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.

Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.