Regulatory Affairs Project Manager

Company: CellCarta
Location: Naperville
Posted on: April 4, 2025

Job Description:

Regulatory Affairs Project ManagerEager to embark on a new professional journey that will transform your career? CellCarta, a leading Contract Research Organization, is hiring a Regulatory Affairs Project Manager to join our dynamic team. As a Regulatory Affairs Project Manager, you will have the opportunity to use your expertise and skills to ensure that our in vitro diagnostic devices meet the highest industry standards. Come work with a team of talented individuals who are committed to making a positive impact on human health and well-being. Apply today and take the first step towards an exciting new career with CellCarta!SummaryThe Regulatory Affairs Project Manager is responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) tests in the US and in international markets, as assigned. The position will work closely with functional business units, perform regulatory review of submission documents, maintain regulatory files, and facilitate regulatory post market surveillance.Responsibilities

• Develops regulatory processes and procedures aligned with global regulatory requirements and trains key personnel in accordance with these processes and procedures.
• Assembles, prepares and/or reviews and submits pre-market authorization/pre-submission packages, supplements, amendments, technical files and other documents to regulatory agencies in line with regulatory requirements and guidelines.
• Interacts effectively with functional business units to coordinate/facilitate development of documentation required for submissions, ensuring that project timelines are met.
• Maintains general working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR and other worldwide regulatory regulations as appropriate and standards, e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs.
• Develops and supports implementation and maintenance of regulatory processes.
• Develops and maintains product labeling (e.g. technical information summaries, instructions for use etc.), advises team on labeling requirements.
• Assist in the development of multi-country regulatory strategy and updates strategy based upon regulatory changes.
• Participates in development teams to provide input on requirements and regulatory strategies for new diagnostic tests.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Monitor changing FDA and EU regulations and guidance to assess regulatory impact on submission strategies and update internal stakeholders.
• Monitor applications under regulatory review and communicate application progress to internal stakeholders.Education

• Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.Main Requirements
  • 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, software development, scientific affairs, operations, or related area. 4-5 years experience in a regulated industry.
  • Demonstrates knowledge and understanding of global regulatory guidelines (i.e. US FDA, ISO13485, IVDR) with proven ability to successfully apply these to work output.
  • Strong project management skills.
  • Exercises judgment within well-defined and established procedures and practices to determine appropriate action.
  • Ability to work independently and in a team environment.
  • Detail-oriented with good organization and time management skills.
  • Strong interpersonal and verbal/written communication skills.
  • Able to respond quickly to shifting priorities and to meeting deadlines.
  • Prior work with IVDs, molecular diagnostics, IHC, PCR-based assays, sequencing technologies and/or CLIA laboratories is highly desirable.Working Conditions
    • Remote position in US or Canada.
    • Flexible working hours to accommodate European colleagues.
    • Potential for travel to global CellCarta locations.BenefitsWe offer a wide range of benefits including:
      • Competitive wages.
      • Medical, dental, and vision benefits.
      • 401k retirement savings plan with a healthy match.
      • Employee Assistance Program (EAP).
      • Vacation and sick time.
      • Referral program.
      • Continuing education.About CellCartaCellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!Join us as we make an impact on patient therapy!Supplemental InformationCandidates must be legally authorized to work in the United States on a permanent basis. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available.
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Keywords: CellCarta, Milwaukee , Regulatory Affairs Project Manager, Executive , Naperville, Wisconsin