- Posted 20 February 2025
- Salary 160,000
- LocationSan Diego
- Job type Permanent
- DisciplineRegulatory
- Reference211735
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Regulatory Affairs Manager
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
- 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