Regulatory Affairs Expert
hace 5 días
Join Vision Achievement as a highly skilled Regulatory Affairs Expert, where you will play a critical role in ensuring the quality and compliance of our life sciences clients. Location: 100% Remote in the USA. Status: Independent Contractor Role.
This exciting opportunity is for experienced professionals with a strong background in RA/QA aspects of life sciences industry sub-sectors such as medical device, in vitro diagnostics, lab-developed tests, pharmaceuticals, clinical manufacturing, and cosmetics. You will be an expert in auditing the design, manufacture, and monitoring of RA/QA under 21 CFR sections and have extensive life sciences experience. We particularly look for individuals with global regulatory coverage - multiple jurisdictions in addition to US, UK, EU.
We offer $120,000 per year, defined by the project, and work alongside a top-rated team. The roles are home-based and require the ability to travel to client sites or deliver virtually. As a self-starter, good communicator, and flexible individual, 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.
Key Responsibilities include:
- Planning and delivering Life Science consulting engagements
- Auditing design and manufacturing processes
- Interpreting and applying codes, regulations, and standards, GMP
- Implementing quality systems planning and implementation, design control, and process validation
- Experience with submissions, remediation, clinical evaluation, post-market surveillance, risk management
You should have a Bachelor's degree in Engineering, Science, or Life Sciences related field, with evidence of progressively taking more responsibility and leading activities in your field. Experience with ancillary standards such as ISO 17025:2017; ISO 14971:2019; ISO 27001:2013; ISO 14155 is a plus. Travel Ability to travel extensively domestically (25% - 50%). Occasional international travel may be required.
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