Manager – Regulatory Affairs

🔥 9 minutes ago

🍂 Massachusetts, Texas – Remote

🍂 Massachusetts – Remote 🤠 Texas – Remote

💵 $124k - $152k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Caris Life Sciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

Biotechnology • Healthcare Insurance • Artificial Intelligence

Caris Life Sciences is a leading innovator in the field of molecular science, focusing on providing cancer patients and oncologists with comprehensive molecular information to revolutionize cancer care. The company specializes in precision medicine, using advanced technologies like molecular profiling and artificial intelligence to understand cancer at a molecular level, offering better treatment options for patients. Caris Life Sciences integrates these technologies with clinical trial solutions and biopharma to enhance cancer research and treatment solutions. Their commitment is to improve as many lives as possible through transformative medical science.

📋 Description

• Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies • Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change • Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, IDEs, supplements, and technical files for CE marketing • Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions • Review and provide regulatory input on analytical and clinical study protocols • Provide support, as needed, for FDA inspections, Pre-Approval Inspections or European Notified Body Inspections • Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes • Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities • Support compliance activities associated with the Quality Management System to fulfill with international and domestic policies and regulations.

🎯 Requirements

• Bachelor’s degree in a science-related area of study • Minimum of 6 years hands-on submission experience including the developing and execution of regulatory strategies for medical device and/or IVD regulated products • Must have knowledge of U.S and European product submission and registration requirements for medical devices and/or IVD regulated products • Strong understanding of product development process, design controls, and ability to effectively partner cross-functionally to develop and influence sound strategies • Ability to work independently, taking ownership for the management of processes, projects, and timelines • Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Remote work options