Regulatory Affairs Expert for Life Sciences

hace 2 días


Madrid, Madrid, España United Staff Source A tiempo completo

Job Summary: We are seeking a highly experienced Regulatory Affairs expert to join our team at United Staff Source. This role is ideal for individuals with significant experience in RA/QA aspects of life sciences industry sub-sectors such as medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, clinical manufacturing, and cosmetics.

About the Role: As a Regulatory Affairs 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. You will have expertise in auditing design and manufacturing, interpretation and application of codes, regulations, and standards, GMP. Additionally, you will have experience with quality systems planning and implementation, design control and process validation, submissions, remediation, clinical evaluation, post-market surveillance, risk management, and ancillary standards such as ISO 17025:2017; ISO 14971:2019; ISO 27001:2013; ISO 14155.

Requirements:

  • Bachelor's degree in Engineering, Science, or a 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

What We Offer: We offer competitive compensation rates, defined by the project, and 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. We seek highly organized individuals who are self-starters, good communicators, and are open to flexible work arrangements, seeking variety in the work they do.

Estimated Salary Range: $80,000 - $120,000 per year, depending on experience.

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