Manager - Regulatory Affairs (Remote)

Job Responsibilities

• 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.

Required Qualifications

• 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.
• 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.

Preferred Qualifications

• Master’s degree in a science-related area of study.
• Prior experience with in vitro diagnostics.
• Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
• Experience leading and/or supporting US FDA submissions.
• Experience in writing/maintaining CE Technical Files.
• Ability to mentor and lead others through challenging circumstances.