Regulatory Assurance Expert
hace 7 días
Location: 100% Remote, in the USA
Status: Independent Contractor Role.
#lifesciences, #consultant, #RAQA This exciting role is for independent contractors with significant experience 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.
We are looking for highly organized individuals who are self-starters, good communicators, and are open to flexible work arrangements, seeking variety in the work they do.
The average salary for this position in the USA is approximately $**120,000-$180,000 per year**, depending on experience and qualifications.
Vision Achievement is a top-rated team offering home-based roles with the ability to travel to client sites for delivery or through virtual technology.
Job DescriptionThis role is primarily that of an individual contributor, although teamwork is expected. You would be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a target product.
Essential Qualifications- Bachelors degree in Engineering, Science, or Life Sciences related field
- Evidence of progressively taking more responsibility and leading activities in their field (such as writing regulatory submissions)
- Significant experience in RA/QA matters related to one or more of medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.
- Experience with auditing design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
- Experience with quality systems planning and implementation, design control and process validation
- Experience with submissions, remediation, clinical evaluation, post-market surveillance, risk management
We have good rates of compensation, defined by the project, and offer a top-rated team to work alongside you. The roles are home-based and require the ability to travel to client sites for delivery, or the ability to deliver through virtual technology.
Key Skills- Confident personality and competent in getting ideas across to others effectively
- Demonstrates ability to work in a team environment, especially when operating remotely
- Passion for patient or consumer safety through effective regulatory and quality activities
- Respect the contribution of all colleagues and facilitate consensus on tough issues
- Demonstrates flexibility in day-to-day working in the team and in approach to unique client issues
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