RIVANNA is seeking a medical device Regulatory Affairs professional to contribute to our emerging medical device company’s rapid growth. You will work within a talented team of professionals as we strive to achieve our 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- and post-market regulatory activities and initiatives. The position will report directly to the Director of Operations and involves frequent written and verbal presentations to Federal government officials.
Key Responsibilities
- Create, present, and execute regulatory strategies for the RIVANNA’s new breakthrough medical device products and R&D programs.
- Work closely with R&D teams to design integrated development plans that ensure regulatory compliance and optimize program efficiency
- Oversee, prepare, and ensure timely submission of high-quality regulatory documents for US and international regulatory authorities
- Track the status of regulatory submissions for R&D programs
- Maintain surveillance on long-range and emerging issues related to regulation in the US and internationally
- Provide interpretive analysis of complex regulatory guidance documents, regulations and directives that affect R&D projects and advise other RIVANNA leadership regarding their applicability and impact
- Provide input and support in the development of policies and procedures related to regulatory affairs
Experience and Qualifications
- Advanced degree (Doctorate preferred) 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 regulatory requirements, procedures and policies related to the conduct of clinical trials/evaluations research
- 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
- Prior experience working on in low-resource settings to lead implementation of regulatory submissions
- High level of attention to detail and significant experience in project management
- Understanding of international complexities and ability to determine most efficient way to regulatory success
- Experience in medical device or ultrasound research working domestic & internationally
- Demonstrated experience in cross-group collaboration in a matrixed environment
- Must have legal authorization to work in the United States.
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