Regulatory Affairs Manager

Company: BioTalent Ltd
Location: San Diego
Posted on: April 1, 2025

Job Description:

Experience

• Minimum 8 years of experience in Regulatory Affairs, of which a minimum of 5 years must be in IVD Regulatory Affairs.
• Minimum 5 years of experience in managing regulatory professionals including responsibility for staffing management, professional development, budget management and adherence with procedures, policies and regulations.
• Demonstrated success in obtaining regulatory approvals in the major geographies including but not limited to the US, EU (under IVDR) and other major geographies.
• Hands-on experience in preparing regulatory submissions including 510(k) and IVDR Technical Documentation and managing relationships and communications with Regulatory Agencies such as FDA, EU Notified Body, etc.
• Experience managing relationships with a variety of stakeholders and cross-functional teams.
• Experience with scientific writing and communications.Skills & Capabilities
  • Strong knowledge of regulatory requirements for obtaining Regulatory Approvals in the United States, EU (under IVDR), Canada, and Australia.
  • Working knowledge of regulatory requirements for obtaining global Regulatory Approvals in Asia Pacific, Latin America and Middle East.
  • Strong knowledge of IVD product development process.
  • Strong knowledge of requirements, methods and data analysis utilized in the analytical and clinical validation of IVD products. Understanding of CLSI guidelines preferred.
  • Strong ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.
  • Strong skills in verbal and written communication including scientific writing and presentation.
  • Strong ability to mentor, train, and develop skills of staff in regulatory knowledge and related processes. Ability to manage and coordinate the activities of direct reports.
  • Strong skills in leadership, influence, and negotiation.
  • Ability to lead cross-functional projects with a focus on collaboration and teamwork to a timely and effective conclusion.
  • Ability to function effectively with ambiguity in a rapidly changing environment.
  • Ability to develop proactive and creative approaches to problem solving.
  • Advanced ability to organize and complete multiple tasks in a fast-paced environment.
  • Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.
  • Advanced knowledge of electronic publishing/file management system.
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Keywords: BioTalent Ltd, San Diego , Regulatory Affairs Manager, Executive , San Diego, California