Regulatory Affairs Manager

Rivanna Medical

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.

About the Company

RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world’s first spinal navigation device designed to improve the safety, speed and efficiency of spinal needle guidance procedures. RIVANNA’s revolutionary platforms feature BoneEnhance®, Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.

Key Responsibilities

  • Create, present, and execute regulatory strategies for the company’s new breakthrough medical device products
  • Make regular presentations internally and externally to industry and government partners
  • Oversee and internally audit the company to global medical device regulations and standards including ISO 13485 and FDA 21 CFR 820
  • Act as management representative and coordinate external audits
  • Continuously improve the company’s SOPs to ensure compliance with changing global medical device regulations
  • Manage substantial change reporting and advisory notices
  • Coordinate with global commercial partners for local regulatory submissions and product clearance
  • Engage FDA through pre-submission, breakthrough, and 510(k) applications
  • Define and manage design transfer documentation, design history files, and technical files

Experience and Qualifications

  • Bachelor’s degree in engineering, regulatory, quality assurance, or similar
  • 4+ years of experience
  • Experience and training to MDSAP, ISO 13845, and FDA 21 CFR 820
  • Internal and external audit management experience
  • Excellent written and verbal communication skills
  • Experience leading FDA pre-submissions, breakthrough designation, and 510(k) applications
  • Familiarity with medical device reimbursement and its intersection with regulatory strategy

Rivanna Medical offers the following employee benefits: health insurance, HSA, paid time off, 401(k), team/family events, and more. We are always looking to complement our existing team with individuals that bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day. As an equal opportunity employer, all applicants receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Sector

Health Tech & Software

Job Type

Full-time

Address

2400 Hunters Way, Charlottesville, VA 22911
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