Regulatory Assurance Specialist
hace 7 días
At Vision Achievement, we are seeking a highly skilled Regulatory Assurance Specialist to join our team. As an independent contractor, you will be responsible for delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure.
About the RoleThe ideal candidate will have significant experience in RA/QA matters related to medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics. You will be expected to work independently, with minimal supervision, and possess excellent communication skills to effectively collaborate with clients.
This is a home-based role that requires occasional travel to client sites or virtual delivery. We offer competitive compensation rates, defined by the project, and the opportunity to work alongside a top-rated team.
Key Responsibilities- Plan and deliver Life Science consulting engagements related to quality/regulatory affairs infrastructure
- Audit design and manufacturing processes, interpreting and applying relevant codes, regulations, and standards
- Develop and implement quality systems, including design control and process validation
- Prepare and submit regulatory documents, such as submissions and remediation plans
- Bachelor's degree in Engineering, Science, or a Life Sciences-related field
- Proven track record of taking on increasingly complex responsibilities and leading activities in your field
- Experience with auditing, quality systems planning, and regulatory compliance
- Experience with international regulations and standards, such as ISO 17025:2017 and ISO 14971:2019
- Knowledge of GMP principles and practices
- Familiarity with clinical evaluation, post-market surveillance, and risk management
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience. If you are a motivated and experienced professional looking for a challenging role, please apply.
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