Quality Regulatory Manager - Charlottesville, United States - RIVANNA

RIVANNA Charlottesville, United States

1 week ago

Upper Management / Consulting

Description

RIVANNA is seeking a medical device Quality Regulatory Manager 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 of improving global healthcare through innovative medical technology. This is a hands-on multidisciplinary role in which the right candidate will actively manage different aspects of RIVANNA's quality management system and regulatory communications. The position will report directly to the Director of Operations with substantial support from the operations team and external regulatory consultants.

Education and Requirements

Bachelor's degree in engineering, regulatory, quality assurance, or similar
4+ years of experience
Experience and training to MDSAP, ISO 13845, and IEC60601
External audit management experience
Experience with FDA pre-submissions and 510(k) applications

Responsibilities

Actively manage and improve the company's MDSAP and ISO 13485-certified quality management system (QMS)
Maintain and oversee RIVANNA's QMS (internal audits, management reviews, corrective and preventive actions, complaints, and supplier management)
Administer and develop company-wide quality management system training
Work with operations team to manage SOPs
Oversee internal audits
Act as management representative and coordinate external audits
Manage substantial change reporting
Perform registrations for Company products
Define and manage design transfer documentation, design history files, and technical files
Engage FDA through pre-submission and 510(k) applications
Support global product registration processes

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, 401(k) with match, and more. We are always looking to complement our existing team with individuals who 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.

RIVANNA Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

About Rivanna Medical, Inc.

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 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 SpineNav3DTM AI-Based Spine Recognition, which automates ultrasound image interpretation.

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