Regulatory Affairs Project Manager

March 8

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CellCarta

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CellCarta is a global contract research organization (CRO) specializing in precision medicine and biomarker development. The company offers a range of testing services, including clinical biomarkers, genomics, proteomics, and histopathology, to support therapeutic development across various fields such as oncology, immunology, and infectious diseases. CellCarta provides advanced technologies like flow cytometry, mass spectrometry, and digital pathology solutions, alongside comprehensive bioinformatics and biostatistics support. With expertise in integrated sample management and logistics, CellCarta partners with clients to navigate the complexities of drug development and ensure effective health solutions.

CRO Laboratory • Oncology • Auto-Immune Diseases • Infectious Diseases • Neurological and Metabolic Disorders

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• The 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. • 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.

🎯 Requirements

• Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. • 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.

🏖️ Benefits

• 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