Regulatory Assurance Specialist
hace 5 días
Regulatory Assurance Specialist - Life Sciences
About Us:Vision Achievement is a leading provider of regulatory and quality assurance services to the life sciences industry.
Compensation:The estimated annual salary for this position is $120,000 - $180,000, depending on experience.
Job Description:We are seeking an experienced Regulatory Assurance Specialist to join our team. In this role, you will be responsible for providing expert guidance on regulatory and quality assurance infrastructure, ensuring compliance with relevant regulations and standards.
Responsibilities:- Provide expert consulting services in the RA/QA domains, specifically focusing on medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, and cosmetics.
- Investigate Out of Specification (OOS) and Out of Trend (OOT) results, considering potential errors in calculation, method/procedure, instrumentation, and sampling.
- Ensure adherence to relevant 21 CFR 2XX and 8XX sections.
- Bachelor's degree in Engineering, Science, or a related Life Sciences field.
- Demonstrated progression in responsibilities, such as leading regulatory submissions.
- Significant RA/QA experience in medical devices, in vitro diagnostics, pharmaceuticals, or cosmetics.
This is a full-time, remote position with competitive compensation and benefits. We offer opportunities for professional growth and development in a dynamic and flexible work environment.
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