Regulatory Expert

hace 4 horas


Madrid, Madrid, España Vision Achievement A tiempo completo

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.

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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.

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Salary
We offer a competitive salary range of $120-$180 per hour, depending on experience, with good rates of compensation defined by the project.

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Job Description
The role primarily involves individual contributor work; however, teamwork is expected. Key responsibilities include:

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  • 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.
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Required Skills and Qualifications
To succeed in this role, you must have:

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  • 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.
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Benefits
As a Regulatory Expert with Vision Achievement, you will enjoy:

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  • 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.
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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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