QA/RA Lead with Project Management Skills
QA/RA Lead with Project Management Skills – Princeton, NJ Full Time
Our Company Story: www.ricovr.com/about-us/
RICOVR Healthcare is an innovative, early-stage biotech startup revolutionizing point-of-care and home-health diagnostics. We were recognized in the Top 10 of technology startups in Princeton 2022 and one of Business Insiders Top 26 startups in 2021. Currently, a gap exists between point-of-care and lab-based diagnostics. While existing point-of-care diagnostic technologies are qualitative and lack sensitivity and accuracy, clinical lab-based technologies are prohibitively expensive and require trained personnel, large equipment, and time-consuming sample analysis. Ricovr Healthcare aims to fill this gap by achieving lab-based machines’ sensitivity, accuracy, and quantification in a portable, low-cost format that enables accurate point-of-care applications for a wide range of health and diagnostic markers.
RICOVR is at an inflection point in bringing this technology to market. We seek a qualified and experienced Quality Assurance and Regulatory Affairs Lead with robust Project Management skills to join our team. This role is essential to guide the team in organizing and tracking work effectively to ensure that all regulatory aspects of the project are compliant. This is an exceptional opportunity for a talented professional to contribute to the growth and success of our innovative organization.
Key Responsibilities:
- Provide Guidance on Best Practices: Offer insights and direction on the regulatory and quality aspects of the organization. Remain aware of new or updated regulations, laws, standards, and other official enactments that may apply to the company.
- Set up Part Numbering System and QMS:Implement a part numbering and Quality Management systems internally or utilize software to enhance operational efficiency.
- Develop Regulatory Submission Plan: Construct a detailed regulatory submission plan, ensuring comprehensive and compliant documentation. Assist in the submission of registration applications. May assist in the preparation of IDE, 510(k), PMA, CE Mark, and other related regulatory filings. Chart pathways to FDA approval for law enforcement, DOT, federal drug program use, and CLIA submission. Manage components Regulatory Approval and Sourcing: Oversee regulatory approval and manage sourcing to ensure quality and compliance for accessories.
- Obtain Appropriate IRBs: Secure necessary Institutional Review Board approvals for user testing and clinical trials to uphold ethical standards.
- Vendor Management and Supply Chain: Manage vendors and supply chain effectively to ensure timely and cost-effective project completion.
- Quality Management: Offer insights and create a plan for managing the quality of reagents, product testing, stability, and labeling to ensure superior product quality.
Qualifications:
- A Bachelor’s of Science Degree in mechanical engineering, industrial engineering, life science, or other related discipline
- 3-5 years in a similar position responsible for in vitro diagnostics or medical device quality engineering duties.
- Regular practice of QA/RA skills and activities.
- Seasoned Project Manager / Change Agent who can manage multiple projects simultaneously.
- Demonstrated experience leading or participating in a successful in vitro diagnostic or medical device product launch.
- Comprehensive knowledge of regulatory standards and quality management systems.
- Strong written and verbal communication abilities with the ability to work closely with engineering and scientific teams to execute successful product launches
Compensation:
- Attractive salary and benefits
- Employee stock options
- Excellent working environment
Join a team dedicated to enhancing the quality and efficiency of healthcare. Make a significant impact in the industry, with career growth and development opportunities.