Kelly Science, Engineering, Technology & Telecom
Senior Regulatory Affairs Specialist, NPD
Kelly Science, Engineering, Technology & Telecom, Sunnyvale, California, United States, 94087
Senior Regulatory Affairs Specialist, NPD
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Senior Regulatory Affairs Specialist, NPD
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Kelly Science, Engineering, Technology & Telecom . Position Overview
Kelly Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a one-year contract with a leading molecular diagnostics company based in Sunnyvale, CA. This role offers an opportunity to contribute to cutting-edge scientific advancements and advance your career in biotechnology. Workplace & Position Details
Workplace:
Onsite in Sunnyvale, CA or Remote US Position Title:
Senior Regulatory Affairs Specialist, New Product Development Type:
One-year contract Pay Rate:
$47-50/hour Key Responsibilities
Evaluate and ensure labeling accuracy for Cepheid’s in vitro diagnostic products. Collaborate with cross-functional teams including Technical Publications, Product Transfer, Quality, R&D, and Clinical Affairs on global change control processes. Review change plans and implemented changes to product labeling/instructions for use. Partner with stakeholders to ensure regulatory compliance of product labeling. Work with Technical Publications to publish regulatory-compliant labeling. Qualifications
Bachelor’s degree with 5+ years of related experience, or Master’s degree with 3+ years, or Doctoral degree with 0-2 years. Deep understanding of Regulatory Affairs concepts, especially related to diagnostic products and labeling claims. Knowledge of Quality Management System regulations (21 CFR Part 820, EN ISO 13485) and change management processes. Strong organizational skills, attention to detail, and ability to prioritize multiple tasks. Proficiency in Microsoft Office and Adobe Acrobat. Preferred Skills
Experience with labeling control, change management, and CAPA processes. Familiarity with Agile documentation systems. Why Join Us
Competitive compensation and potential for permanent placement. Work at the forefront of biotechnology innovation. Access to career development and networking through Kelly Science & Clinical. Additional Information
Kelly offers comprehensive benefits including medical, dental, vision, life insurance, retirement plans, and more. Kelly is committed to equal employment opportunity and complies with all applicable laws.
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Join to apply for the
Senior Regulatory Affairs Specialist, NPD
role at
Kelly Science, Engineering, Technology & Telecom . Position Overview
Kelly Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a one-year contract with a leading molecular diagnostics company based in Sunnyvale, CA. This role offers an opportunity to contribute to cutting-edge scientific advancements and advance your career in biotechnology. Workplace & Position Details
Workplace:
Onsite in Sunnyvale, CA or Remote US Position Title:
Senior Regulatory Affairs Specialist, New Product Development Type:
One-year contract Pay Rate:
$47-50/hour Key Responsibilities
Evaluate and ensure labeling accuracy for Cepheid’s in vitro diagnostic products. Collaborate with cross-functional teams including Technical Publications, Product Transfer, Quality, R&D, and Clinical Affairs on global change control processes. Review change plans and implemented changes to product labeling/instructions for use. Partner with stakeholders to ensure regulatory compliance of product labeling. Work with Technical Publications to publish regulatory-compliant labeling. Qualifications
Bachelor’s degree with 5+ years of related experience, or Master’s degree with 3+ years, or Doctoral degree with 0-2 years. Deep understanding of Regulatory Affairs concepts, especially related to diagnostic products and labeling claims. Knowledge of Quality Management System regulations (21 CFR Part 820, EN ISO 13485) and change management processes. Strong organizational skills, attention to detail, and ability to prioritize multiple tasks. Proficiency in Microsoft Office and Adobe Acrobat. Preferred Skills
Experience with labeling control, change management, and CAPA processes. Familiarity with Agile documentation systems. Why Join Us
Competitive compensation and potential for permanent placement. Work at the forefront of biotechnology innovation. Access to career development and networking through Kelly Science & Clinical. Additional Information
Kelly offers comprehensive benefits including medical, dental, vision, life insurance, retirement plans, and more. Kelly is committed to equal employment opportunity and complies with all applicable laws.
#J-18808-Ljbffr