RIVANNA is seeking a medical device Quality Regulatory Manager 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 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.
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.
Key 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
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 IEC60601
- External audit management experience
- Experience with FDA pre-submissions and 510(k) applications
Sector
Job Type
Salary Range
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
Address
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