Regulatory Expert
hace 4 horas
Company Overview
Vision Achievement is a leading provider of regulatory and quality assurance services to the life sciences industry. Our team of experts works closely with clients to ensure compliance with relevant regulations and standards.
About the Role
This exciting opportunity is for an independent contractor or contract-for-hire with significant experience in RA/QA matters related to medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics. As a Regulatory Expert, you will 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.
Salary
We offer a competitive salary range of $120-$180 per hour, depending on experience, with good rates of compensation defined by the project.
Job Description
The role primarily involves individual contributor work; however, teamwork is expected. Key responsibilities include:
- Conducting audits of design and manufacturing processes, ensuring compliance with relevant codes, regulations, and standards;
- Developing and implementing quality systems plans and designing control procedures;
- Managing submissions, remediation, clinical evaluation, post-market surveillance, and risk management activities;
- Traveling extensively domestically (25%-50%) and occasionally internationally.
Required Skills and Qualifications
To succeed in this role, you must have:
- A Bachelor's degree in Engineering, Science, or a related field;
- Evidence of progressively taking more responsibility and leading activities in your field, such as writing regulatory submissions;
- Significant experience in RA/QA matters related to one or more of the mentioned industries;
- Familiarity with GMP, quality systems planning, and process validation;
- Experience with submissions, remediation, clinical evaluation, post-market surveillance, and risk management;
- Certifications like ISO 17025:2017, ISO 14971:2019, ISO 27001:2013, and ISO 14155 are a plus;
- Excellent communication and problem-solving skills.
Benefits
As a Regulatory Expert with Vision Achievement, you will enjoy:
- A competitive salary range;
- Opportunities for professional growth and development;
- A dynamic and supportive work environment;
- The ability to work independently and as part of a team;
- The chance to make a meaningful impact on patient safety and population health improvement.
Others
Vision Achievement is an equal opportunities employer committed to diversity and inclusion. We welcome applications from qualified candidates who share our vision and values.
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