• Job Description

  Req#: 32505932333
  Regulatory Affairs & Post-Market Analyst
  
  Hercules, CA **Onsite- local candidates only
  
  $45hr-$48hr ( Weekly pay + medical benefits)
  
  12 month contract ( Great potential for extension and permanent )
  
  Full-time M-F Can start anytime between 7am-9am ( 40hrs a week)
  
  Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives!
  
  This role focuses on managing post-market surveillance activities, particularly around scientific evaluations and ensuring products maintain regulatory compliance after being launched. The position involves working cross-functionally with various teams to gather data, analyze findings, and ensure reports are generated on time. You will ensure that the company's products remain compliant with regulatory standards by conducting continuous post-market evaluation, ensuring safety and performance data is up-to-date. Your role will contribute to the development of new products and the optimization of existing ones by supporting the analysis of product benefits and risks based on real-world evidence.
  
  Post Market Performance Follow (PMPF) Analyst
  
  Key Responsibilities:
  
  • Execute PMPF processes: Manage and oversee the generation and scheduling of Post Market Performance Follow-Up (PMPF) reports to ensure tasks are carried out in line with timelines and standards.
  • Cross-functional coordination: Work closely with R&D, Clinical Affairs, Marketing, and RA/QA teams to gather necessary inputs for the reports and revise PMPF plans or Periodic Safety Update Reports (PSUR) as needed.
  • Literature review: Analyze scientific literature related to product performance and summarize findings in protocol reports to assess the product's benefit-risk profile.
  • Ensure alignment with timelines: Ensure that PMPF deliverables are aligned with the PSUR publication timeline and prioritized accordingly.
  • Contribute to product development: Participate in new product development and sustaining projects, ensuring tasks are completed accurately and on time, including conducting laboratory studies when necessary.
  Required Qualifications & Experience:
  • Educational Background: A BS in a science-related field (Biochemistry, Biotechnology, Chemistry, or similar).
  • Experience: 1-3 years of experience in the industry. - Either in Post Market Surveillance Analyst, Regulatory Affairs Analyst or similar
  • Background in life sciences, biotechnology, or clinical research who are looking to dive into post-market performance and regulatory compliance, particularly within the in-vitro diagnostics or medical device industries
  • Laboratory experience: At least 1 year of laboratory experience, with knowledge in immunoassays, infectious diseases, bacteriology, and related diagnostic techniques.
  • Bonus: Industry preference: Experience in the in-vitro diagnostics industry, with knowledge of IVDR (Regulation 2017/746), is preferred.
  • Analytical skills: Strong logical, analytical, and methodical approach to problem-solving.
  • Language proficiency: Advanced proficiency in English (both written and spoken).
  • Software proficiency: Proficient in Microsoft Word, Excel, PowerPoint, OneDrive, SharePoint, and Teams.
  
  
  TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.

• About the company

Notice