Senior Regulatory Affairs Specialist
ABOUT WARWICK CONSULTING Warwick Consulting is a comprehensive medical device and life sciences consulting firm that simplifies complexity across the full product lifecycle—from concept and design through regulatory approval, commercialization, and post-market support. We partner with organizations ranging from early-stage innovators to global industry leaders, delivering tailored, results-driven solutions across engineering, quality systems, regulatory affairs, cybersecurity, risk management, human factors engineering, product quality, and FDA remediation. By integrating deep industry expertise with innovative, AI-enabled solutions, including our VERA QMS Assurance platform, we help clients address complex challenges, strengthen compliance, improve operational efficiency, and accelerate innovation. Our experienced consultants provide flexible on-site, hybrid, and remote support, delivering the right expertise when and where it is needed most. Position Overview: The Senior Regulatory Affairs Specialist will serve as a key technical contributor in executing our client’s global regulatory strategies and preparing submission filings for our pipeline of Software-as-a-Medical-Device (SaMD) and AI/ML cardiovascular solutions. Reporting to the Director of Regulatory Affairs, this individual will author regulatory submissions, interface directly with cross-functional software and clinical engineering teams and ensure global compliance across product lifecycles. By embedding regulatory requirements early into the software development lifecycle, this role ensures that innovative AI-driven algorithms meet FDA, EU MDR, and international regulatory standards efficiently and thoroughly. Responsibilities: SaMD Regulatory Strategy & Planning · Evaluate regulatory risks, classification impact, and pathway options (e.g., FDA 510(k), De Novo, CE Mark) for new AI/ML software features, algorithm updates, and Predetermined Change Control Plans (PCCPs). · Execute global registration strategies for Class II SaMD algorithms in target international markets, including the US, Europe, Singapore, KSA (Saudi Arabia), and UAE (United Arab Emirates), under the direction of Regulatory leadership. · Assess proposed software design modifications and algorithm enhancements to determine necessary filing updates, documentation requirements, or re-clearance triggers. · Align regulatory project timelines with Agile sprint planning, product release schedules, and clinical validation milestones. Submissions Execution & Agency Interactions · Author, compile, and format high-quality regulatory submissions, including FDA 510(k)s, De Novo applications, CE Mark technical documentation under EU MDR, and international registration dossiers. · Coordinate and draft responses to health authority information requests, deficiency letters, and technical review queries from the FDA, European Notified Body, and international regulatory agencies. · Support regulatory leadership in preparing pre-submission meeting packages and background materials for FDA (specifically CDRH) and Notified Body interactions. · Assist in maintaining post-market surveillance (PMS) files, medical device vigilance, and adverse event reporting documentation in compliance with global regulations. · Critically review clinical protocols, validation reports, software documentation, and labeling to ensure submission readiness. Cross Functional Collaboration & Product Lifecycle Integration · Serve as the embedded regulatory representative on cross-functional core teams, partnering with Engineering, Data Science, Product, and Clinical teams throughout the Agile software development lifecycle. · Review and provide regulatory input on Design Controls, including Design History Files (DHF), Software Requirements Specifications (SRS), Verification & Validation (V&V) protocols, and ISO 14971 Risk Management files. · Collaborate with Quality team members to support Quality Management System (QMS) compliance with ISO 13485, MDSAP, and FDA 21 CFR Part 820 / QMSR standards, supporting software change control workflows. · Actively participate in audit preparation, hosting activities, and technical file presentation for MDSAP surveillance audits, FDA inspections, and Notified Body assessments. · Perform regulatory reviews and clearance of promotional materials, marketing assets, and Instructions for Use (IFU) to ensure compliance with cleared indications for use. Regulatory Intelligence & Project Leadership · Monitor and summarize evolving global SaMD regulations, standards, and guidance documents (e.g., EU MDR, EU AI Act, FDA SaMD cybersecurity guidance, IMDRF standards) into practical guidance for engineering and product teams. · Provide informal mentorship and technical guidance to junior regulatory staff, contractors, or cross-functional team members on regulatory requirements and submission best practices. · Maintain organized regulatory submission archives, registration tracking databases, and global product clearance logs. Requirements: · Bachelor’s degree in a STEM field (Engineering, Computer Science, Life Sciences, or related technical discipline). · 4–6 years of progressive regulatory affairs experience in the medical device industry, with a primary focus on Class II Software as a Medical Device (SaMD) and digital health. · Proven track record of authoring and compiling successful regulatory submissions for SaMD products with the FDA (510(k) or De Novo) and ex-US authorities (such as CE Mark technical files, Singapore HSA, Saudi Arabia SFDA, or UAE MoHAP). Direct experience authoring technical documentation is required. · Strong working knowledge of medical device software standards, quality regulations, and frameworks, including IEC 62304 (Medical Device Software - Software Lifecycle Processes), ISO 13485, ISO 14971 (Risk Management), MDSAP, and FDA 21 CFR 820 / QMSR. · Hands-on experience preparing for and responding to regulatory agency questions, pre-submission feedback, and supporting regulatory audits/inspections (such as MDSAP, FDA, or Notified Body audits). · Excellent technical writing, analytical, and communication skills, with a demonstrated ability to translate software design and clinical validation concepts into clear regulatory arguments. · Ability to work effectively in fast-paced, collaborative, agile software development environments. · This role is remote but does require 10% to 15% domestic travel. Preferred Qualifications: · Advanced degree (MS, PhD, or MBA) in a scientific, engineering, or regulatory discipline. · Regulatory Affairs Certification (RAC-Devices) from RAPS or equivalent professional credential. · Direct experience with AI/ML-enabled medical devices, including familiarity with FDA AI/ML software guidance, Predetermined Change Control Plans (PCCPs), and algorithm change protocols. · Experience preparing, submitting, and managing PMA (Premarket Approval) applications and IDEs (Investigational Device Exemptions) for Class III medical devices. · Background in cardiovascular diagnostics, ECG software, or digital health platforms. · Experience working in high-growth digital health startups or agile medtech companies. Equal Opportunity Employer We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law. l.