Senior Life Sciences Consultant for Regulatory Affairs and Quality Assurance
hace 4 días
As a Senior Life Sciences Consultant with Vision Achievement, you will provide expert guidance on regulatory and quality assurance infrastructure, ensuring compliance with relevant regulations and standards. Your responsibilities will include investigating Out of Specification (OOS) and Out of Trend (OOT) results, ensuring adherence to 21 CFR sections, and leading consulting engagements. You will work closely with clients to deliver high-quality solutions, leveraging your expertise in design and manufacturing processes, quality systems planning, and regulatory submissions.
About You:
We are looking for a seasoned professional with significant experience in RA/QA, preferably in medical devices, pharmaceuticals, or cosmetics. You must have a Bachelor's degree in Engineering, Science, or a related field and demonstrated leadership experience in regulatory submissions. Proficiency in GMP and other standards is essential, as well as knowledge of ancillary standards like ISO 17025:2017, ISO 14971:2019, and ISO 27001:2013. Strong communication and team player skills are also required, as you will be working remotely with clients and colleagues.
What We Offer:
Vision Achievement offers competitive compensation rates based on project-specific requirements, ranging from $120,000 to $180,000 annually, depending on experience. Additionally, you will have the opportunity to collaborate with a top-rated team in a dynamic and flexible work environment.
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