QA/RA Lead with Project Management Skills
Currently, a gap exists between point-of-care and lab-based diagnostics. Existing point-of-care diagnostic technologies are qualitative, lacking sensitivity and accuracy. In contrast, clinical lab-based technologies are expensive and require trained personnel, large equipment, and time-consuming sample analysis. RICOVR Healthcare aims to fill this gap by achieving the sensitivity, accuracy, and quantification of lab-based machines in a portable, low-cost platform that enables true point-of-care application for a wide range of health and diagnostic markers.
RICOVR Healthcare’s platform technology utilizes a novel optic biosensor combined with functionalized plasmonic nanoparticles to enable quantitative immunoassays at the point-of-care. We are at an inflection point in bringing this technology to market and seek to expand our scientific team. If you want to be part of commercializing a new technology at the interface of biology, chemistry, engineering, and healthcare while working with innovative and driven colleagues, then you should reach out to us!
Key Responsibilities:
- Provide Guidance on Best Practices: Offer insights and direction on the organization’s regulatory and
quality aspects. 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 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 preparing 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
If the opportunity to join a growing startup excites you and you are a great fit for the above role, please apply below. We are an Equal Opportunity Employer. If you have questions about this role, please email us at [email protected].
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