Regulatory Project Manager
RIVANNA is seeking a medical device Regulatory Project Manager to contribute to their emerging medical device company’s rapid growth. You will work with a talented team of professionals as they strive to achieve their mission to elevate global standards of care with world-first medical imaging technology.
This is a hands-on multidisciplinary role in which the right candidate will actively manage and execute different aspects of RIVANNA’s pre-market regulatory activities and initiatives. The position will report directly to the Director of Program Management and involves frequent written and verbal presentations to Federal government officials.
Joining RIVANNA as a Regulatory Project Manager offers an exciting opportunity to make a significant impact on our regulatory success and contribute to the growth of our organization. If you are a highly motivated and detail-oriented regulatory professional with strong project management skills, we encourage you to apply and be part of our dedicated team working towards delivering life-changing products in compliance with regulatory standards.
- Create, present, and execute premarket regulatory strategies for RIVANNA’s new breakthrough medical device products and R&D programs.
- Coordinate and assist in preparing high-quality regulatory submissions, including premarket notifications 510(k), De Novo approval applications, and post-approval submissions.
- Liaise with cross-functional teams, such as R&D, Quality Assurance/Regulatory Affairs, and clinical teams, to gather necessary documentation and data for submissions.
- Coordinate with external regulatory consultants for premarket regulatory project execution and management.
- Maintain surveillance on long-range and emerging issues related to regulation in the US and internationally.
- Monitor, assess, and provide concise summaries of FDA regulations, guidance, and industry updates relevant to RIVANNA’s product portfolio.
- Communicate regulatory changes and recommendations to internal stakeholders to ensure proactive compliance.
- Organize and maintain project timelines, deliverables, and milestones related to premarket regulatory activities.
- Track project progress, identify potential bottlenecks, and facilitate problem-solving to ensure on-time completion of regulatory milestones in coordination with other stakeholders.
- Maintain accurate and up-to-date records of all premarket regulatory activities, ensuring that documentation is compliant with FDA requirements.
- Generate reports and summaries for management and regulatory authorities as necessary.
- Review and monitor regulatory compliance for clinical studies.
- Assist clinical team with regulatory aspects of clinical study IRB submissions and approvals.
- Responsible for all regulatory aspects of future FDA-regulated study execution.
- Monitor, assess, and provide concise summaries of FDA-regulated medical device clinical trials, 510(k) clearances, De Novo clearances for products close to our product line for competitive analysis.
Experience and Qualifications
- Advanced degree or bachelor’s degree (required) plus at least five years of regulatory affairs experience or ten years of product development experience as a major contributor to regulatory submissions.
- Demonstrated knowledge of FDA regulations, guidance, and relevant industry standards and procedures and policies related to the conduct of clinical trials/evaluations research.
- Proven experience in preparing FDA submissions and interacting with regulatory agencies.
- Experience with medical devices required, software as a medical device, and/or computer-assisted detection devices preferred.
- Demonstrated experience applying creative solutions to complex issues and problems with an open mind and can-do attitude.
- Excellent oral and written communication skills and interpersonal skills.
- High level of attention to detail and significant experience in project management.
- Ability to work independently and collaboratively in a cross-functional environment.
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