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Senior Regulatory Affairs Manager (m/f)


  • Bachelor of Science ore Master's degree (preferred) nature scientific (e.g. Biology, Chemistry)
  • Minimum 5 years relevant regulatory experience with Class III medical devices
  • Previous experience with implants or other medical devices drug combination products
  • Deep knowledge on risk management according to EN ISO 14971
  • Proven track record of leading regulatory strategies, preparing quality dossiers and delivering on-time approvals, with a creative approach
  • Strong knowledge of regulations and guidances in the US and EU
  • Knowledge of the device development process and post approval requirements
  • Experience at effectively interacting and negotiating with regulatory agencies
  • Development and execution of global regulatory strategies for new and life-cycle of medical device
  • Maintenance of design dossier for medical device, including participation in regular audit by notified bodies
  • Effective regulatory strategies that incorporate global clinical and regulatory requirements that achieve a rapid approval
  • Identify and assess regulatory risks, opportunities and project issues, and make recommendations to regulatory Management
  • Taking on the lead in the product risk management team
  • Successful execution of global regulatory strategies
  • Participate in product teams with regard to implementation of regulatory strategy and requirements
  • Compliance with regulatory requirements, and corporate and team strategy
  • Lead strategy and submission content for responding to global authorities request for additional information and other inquiries Responses to global authorities are successful and timely
  • Represents regulatory to the supervisory boards
  • Support commercialization activities of new products
  • Serve as primary contact for global regulatory authority interactions and communications on responsible projects
  • Positive relationship, constructive, focused feedback and successful negotiation
  • Prepare and plan for meetings with regulatory agencies
  • Conduct and analyse regulatory intelligence research providing guidance to project teams precedent and competitive landscape
  • Successful execution of competitive regulatory strategies
  • Maintains current knowledge of new and emerging regulations guidances and changes in regulatory authority infrastructure
  • Communicates to internal stakeholders the interpretation and implications of this information
  • Successful monitoring, appropriate interpretation on business impact and communication
  • Contribute with knowledge and experience for development, improvement and optimization of internal processes, e.g. in workshops and taskforces


» Job description


Employer:
Merz Pharmaceuticals GmbH
Location:
60318 Frankfurt am Main


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