Senior Regulatory Compliance Specialist
hace 16 horas
Job Overview: Vision Achievement seeks highly organized and self-starting individuals to join our team as a Senior Regulatory Compliance Specialist. This exciting role is for independent contractors with significant experience in RA/QA aspects of life sciences industry sub-sectors such as medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, clinical manufacturing, and cosmetics. You will likely be an expert in auditing the design, manufacture, and monitoring of RA/QA under 21 CFR sections and have wide life sciences experience.
About the Role: As a Senior Regulatory Compliance Specialist, you will plan and deliver Life Science consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a target product. The role is primarily that of an individual contributor, although teamwork is expected.
Key Responsibilities:
- Plan and deliver high-quality consulting engagements related to quality/regulatory affairs infrastructure.
- Audit the design, manufacture, and monitoring of RA/QA under 21 CFR sections.
- Work closely with clients to understand their needs and develop effective solutions.
- Demonstrate expertise in auditing and regulatory compliance.
Person Description: We are looking for a confident and competent individual who can effectively communicate ideas across various teams. You should demonstrate flexibility in day-to-day working and approach unique client issues with ease. Our ideal candidate has:
- Bachelor's degree in Engineering, Science, or Life Sciences related field.
- Progressively taken on more responsibility and led activities in their field.
- Significant experience in RA/QA matters related to one or more of medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.
Compensation: We offer a competitive salary of $120,000 - $180,000 per year, depending on experience. The role is home-based, and we require the ability to travel to client sites for delivery or deliver through virtual technology. If you're a self-starter with excellent communication skills and a passion for patient safety and population health improvement, we encourage you to apply for this exciting opportunity.
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