Life Sciences Consultant
hace 4 días
**Vision Achievement**: A Top-Rated Team for Life Sciences Consulting Experts
We are seeking highly organized and self-starting individuals with significant experience in RA/QA aspects of life sciences industry sub-sectors such as medical devices, in vitro diagnostics, lab developed tests, pharmaceuticals, and cosmetics.
The role involves designing, manufacturing, and monitoring RA/QA under 21 CFR sections and requires wide life sciences experience. We seek consultants, auditors, and instructors who have expertise and a passion for patient safety and population health improvement.
As an independent contractor or contract-for-hire, you will be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a target product.
Essential Qualifications:
- Bachelor's degree in Engineering, Science, or a Life Sciences related field
- Evidence of progressively taking more responsibility and leading activities in their field (such as writing regulatory submissions)
- Significant experience in RA/QA matters related to one or more of medical devices, in vitro diagnostics, pharmaceuticals, cosmetics
- Leading the instruction of Life Sciences experts in RA/QA matters
Industry Requirements:
- Experience with design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
- Experience with quality systems planning and implementation, design control, and process validation
- Experience with submissions, remediation, clinical evaluation, post-market surveillance, risk management
- Ability to travel extensively domestically (25% - 50%) and occasionally internationally
We offer competitive compensation rates, defined by project, and flexible work arrangements. If you have a passion for patient or consumer safety through effective regulatory and quality activities, we encourage you to apply.
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