Regulatory Affairs and Quality Assurance Consultant in Life Sciences
hace 4 días
We are seeking an experienced independent contractor with a strong background in Regulatory Affairs (RA) and Quality Assurance (QA) within the life sciences industry. This role involves providing expert consulting services in the RA/QA domains, specifically focusing on medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, and cosmetics.
The ideal candidate will have significant experience in designing, manufacturing, and monitoring RA/QA under relevant regulations and standards. Their deep commitment to patient safety and population health improvement will be essential in ensuring compliance with industry requirements.
Key Responsibilities:
- Consulting & Auditing: Provide expert guidance on regulatory and quality assurance infrastructure, ensuring compliance with relevant regulations and standards.
- Investigation of OOS/OOT Results: Conduct thorough investigations of Out of Specification (OOS) and Out of Trend (OOT) results, considering potential errors in calculation, method/procedure, instrumentation, and sampling.
- Compliance: Ensure adherence to relevant regulations and standards.
- Project Leadership: Plan and deliver consulting engagements, often as an individual contributor, but with an emphasis on teamwork.
- Communication: Effectively communicate ideas and solutions to clients and team members.
Required Skills and Qualifications:
- Bachelor's degree in Engineering, Science, or a related Life Sciences field.
- Leadership Experience: Demonstrated progression in responsibilities, such as leading regulatory submissions.
- Industry Experience: Significant RA/QA experience in medical devices, in vitro diagnostics, pharmaceuticals, or cosmetics.
Estimated Salary Range:$100,000 - $150,000 per year, based on location and experience.
About Vision Achievement:
Vision Achievement is committed to advancing safety and compliance in the life sciences industry. We offer competitive compensation rates determined by the specific project, and our team is dynamic and flexible.
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