Regulatory Affairs Specialist – Innovation

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Offer regulatory guidance to teams developing new products for in vitro diagnostic devices, automated laboratory systems, and associated software products.

• Formulate regulatory strategies and perform risk assessments.

• Act as the Regulatory Affairs subject matter expert within new product development teams.

• Collaborate across functions including R&D, Medical Affairs, Quality, Marketing, Program Management, and others.

• Identify and mitigate potential regulatory risks in project plans.

• Organize and oversee submissions to the FDA and EU IVDR.

• Prepare FDA submissions such as Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications.

• Compile EU IVDR Technical Files/Dossiers.

• Serve as the point of contact for FDA and Notified Body review teams during submission evaluations and communications.

• Identify and recommend ongoing process enhancements.

⛳️ Requirements

• A Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or a related scientific/technical field.

• 2–5 years of relevant regulatory experience with in vitro diagnostic devices and/or medical devices.

• Consideration may be given to experience in IVDs, medical devices, laboratory systems, or similar regulatory healthcare technologies.

• Experience in interpreting complex and subjective regulatory requirements.

• Knowledge of advanced technical/scientific principles across varied or complex product lines or manufacturing processes.

• Background in supporting product development and product support initiatives.

• Experience in preparing, filing, and/or completing regulatory submissions, ideally as the primary author.

• Capacity to analyze intricate issues and devise effective solutions.

• Ability to use independent judgment and discretion.

• Proficient in managing multiple tasks and effectively prioritizing and scheduling work with minimal oversight.

• Experience in coordinating cross-functional contributions from R&D, Quality, Medical Affairs, Program Management, and Marketing.

• Capability to compile and review documentation for FDA submissions and EU IVDR documentation.

• Familiarity with regulatory submission processes and lifecycle management.

• Strong written and verbal communication abilities.

• Experience working with dynamic, cross-functional teams.

• Knowledge of SOPs, regulatory procedures, and quality systems such as ISO 13485.

• Excellent organizational skills with the ability to manage multiple submissions/projects concurrently.

• Flexibility in adapting to changing timelines and priorities.

• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits packages.

• Opportunities for learning, growth, and development.

• Workplace accommodations considered in accordance with applicable law.

• Considerations for a flexible work-life balance.