Responsibilities:

Provide regulatory guidance to cross-functional teams supporting new product development, design changes, risk management, commercialization, and product lifecycle activities Perform and maintain regulatory assessments for product modifications, software and firmware updates, labeling changes, manufacturing changes, and new product development activities Serve as the Regulatory Affairs project lead for FDA and international regulatory submissions, developing submission strategies, timelines, deliverables, and cross-functional execution plans Prepare, review, compile, and submit regulatory applications, technical documentation, and responses to regulatory authorities Support and manage U.S. regulatory submissions, including 510(k) submissions and other applicable premarket activities Support international regulatory submissions and registrations across applicable global markets Maintain product registrations, establishment registrations, regulatory listings, licenses, and other required regulatory records Track regulatory commitments, submission milestones, renewals, and reporting requirements to ensure timely completion Serve as a primary Regulatory Affairs liaison with external partners, including European Authorized Representatives, regulatory consultants, and applicable regulatory authorities Review and approve promotional, advertising, labeling, and marketing materials to ensure compliance with applicable regulations and approved product claims Lead post-market regulatory reporting and vigilance activities, including assessment, submission, tracking, and documentation of reportable events Perform Medical Device Reporting (MDR) assessments and support reporting determinations in accordance with applicable regulatory requirements Collaborate with Quality, Clinical Affairs, and Post-Market Surveillance teams to support complaint trend reporting, PSURs, periodic regulatory reports, and other post-market deliverables Administer and maintain regulatory electronic submission platforms and accounts, including FDA Electronic Submission Gateway (ESG), WebTrader, and other applicable regulatory systems Monitor evolving U.S. and international regulatory requirements and assess potential impacts to products, processes, registrations, and regulatory strategies Communicate regulatory changes, risks, requirements, and recommendations to cross-functional stakeholders and leadership Support regulatory inspections, audits, agency inquiries, and Quality System activities related to Regulatory Affairs Identify opportunities to improve regulatory processes, documentation, tracking, and cross-functional execution as the organization grows

Requirements:

Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related scientific or technical discipline Minimum of 5 years of Regulatory Affairs experience within the medical device industry Demonstrated experience with medical device regulatory submissions, post-market regulatory compliance, and product lifecycle management Strong working knowledge of FDA medical device regulations, Medical Device Reporting requirements, and applicable international regulatory frameworks Experience performing regulatory assessments for new product development, design changes, software or firmware updates, labeling changes, and product modifications Experience preparing, supporting, or managing 510(k) submissions Experience supporting international or OUS medical device registrations and submissions Knowledge of post-market vigilance requirements, complaint reporting, MDR assessments, and applicable regulatory reporting obligations Experience reviewing promotional, advertising, labeling, or marketing materials for regulatory compliance Strong project management skills with demonstrated ability to coordinate complex regulatory deliverables across multiple functions Strong technical writing skills with experience preparing regulatory documentation and communicating complex information clearly Ability to independently manage multiple regulatory projects, priorities, and deadlines Excellent written and verbal communication skills with the ability to collaborate effectively with internal stakeholders, external partners, and regulatory authorities Strong attention to detail and commitment to regulatory documentation accuracy and compliance

Preferred Qualifications:

Advanced degree in Regulatory Affairs, Engineering, Life Sciences, or a related discipline Regulatory Affairs Certification (RAC) Experience within a startup or growth-stage medical device organization Experience serving as the regulatory lead or project manager for successful 510(k) submissions Experience with EU MDR and international medical device registrations Experience supporting connected, wearable, software-enabled, or electro-medical devices Experience with software and firmware change assessments Experience preparing or supporting PSURs and other post-market regulatory deliverables Experience interacting directly with FDA or other regulatory authorities Experience supporting FDA inspections, notified body audits, or other regulatory inspections

Compensation:

Base Pay:

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