Director, Regulatory Affairs

Director, Regulatory Affairs

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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.

Overview:

The Director of Regulatory Affairs will own and drive Warwick Consulting's clients global regulatory strategy across the full product lifecycle, ensuring accelerated market access for our pipeline of Software-as-a-Medical-Device (SaMD) and AI/ML cardiovascular solutions. This role serves as the regulatory lead for the client, managing interactions with regulatory authorities (such as the FDA and EU Notified Body) and driving the preparation, submission, and approval of breakthrough AI-driven algorithms. By embedding regulatory intelligence early in the software development lifecycle, this leader will enable product innovation, mitigate compliance risks, and align regulatory milestones.

Responsibilities:

SaMD Regulatory Strategy & Planning

· Translate business objectives and product roadmaps into robust regulatory strategies for Class II AI/ML-enabled Software-as-a-Medical-Device (SaMD).

· Evaluate and communicate regulatory risks, trade-offs, and mitigation plans for novel diagnostic and perioperative ECG algorithms.

· Lead global market access strategy, identifying efficient regulatory review pathways (e.g., FDA 510(k), De Novo, CE Mark) to support rapid portfolio expansion in the US, Europe, and key international jurisdictions such as Singapore, KSA (Saudi Arabia), and UAE (United Arab Emirates).

· Align regulatory strategies with commercial priorities, reimbursement considerations, and clinical study outcomes.

Submission Execution & Agency Interaction

· Manage the end-to-end preparation, authoring, and prosecution of regulatory submissions (including FDA 510(k), De Novo, CE Mark, and other international registrations) to ensure high-quality, complete, and timely filings across key jurisdictions.

· Serve as the primary contact and regulatory lead for all interactions with the FDA (specifically CDRH) and ex-US health authorities, including coordinating pre-submission meetings, managing interactive reviews, and responding to deficiencies.

· Own the relationship and day-to-day management of our clients European Notified Body, ensuring seamless technical file reviews under EU MDR, coordinating conformity.

· assessment audits, and strategically leading Notified Body maintenance, selection, and transfer/transition activities as needed.

· Oversee global post-market regulatory compliance, including managing adverse event reporting, regulatory vigilance, and post-market surveillance (PMS) reporting in accordance with FDA and international requirements.

· Critically review clinical protocols, study reports, software design documentation, and validation data to ensure alignment with FDA standards and global guidelines.

Cross Functional Collaboration & Product Life Cycle Integration

· Partner cross-functionally with Engineering, Product, Clinical, Data Science, and Commercial teams to embed regulatory requirements and Design Controls into the Agile software development lifecycle (SDLC).

· Provide regulatory subject matter expertise for Design History File (DHF) development, Software Requirements Specifications (SRS), and software verification and validation.

· Collaborate closely with the Quality team to ensure the Quality Management System (QMS) conforms to ISO 13485, MDSAP, and FDA 21 CFR Part 820 requirements, supporting software change control and algorithm update protocols.

· Support the maintenance of our clients Medical Device Single Audit Program (MDSAP) certification, partnering with Quality to ensure compliance across member jurisdictions and playing an active role in audit preparation, hosting, and response coordination for FDA, MDSAP, and Notified Body audits.

· Perform regulatory review and clearance of promotional, marketing, and labeling materials to ensure compliance with cleared indications for use.

Regulatory intelligence and Strategic Compliance

· Establish and lead a proactive regulatory intelligence program to monitor evolving global regulations, guidelines, and standards (e.g., EU MDR, EU AI Act, FDA SaMD cybersecurity guidance, and IMDRF standards).

· Translate complex, emerging AI/ML and software regulatory guidance into actionable recommendations for executive leadership and product roadmaps.

· Provide regulatory assessments and due diligence opinions on strategic partnerships, in-licensing opportunities, and new business initiatives to the Chief Business Officer and senior leadership.

· Mentor, build, and potentially manage a small, high-performing team of regulatory professionals and outsourced consultants; develop and manage budgets for regulatory operations to support company goals.

Requirements:

Bachelor's degree in a STEM field (Engineering, Computer Science, Life Sciences, or related technical discipline).

· 8+ 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 successful regulatory submissions and clearance/approval of SaMD products with the FDA (510(k) or De Novo) and ex-US authorities (such as CE Mark, Singapore HSA, Saudi Arabia SFDA, UAE MoHAP, or other international jurisdictions). Direct experience writing/authoring technical documentation is required.

· Deep knowledge of medical device software standards, regulations, and quality frameworks, including IEC 62304 (Medical Device Software - Software Lifecycle Processes), ISO 13485, ISO 14971 (Risk Management), MDSAP, and FDA 21 CFR 820.

· Demonstrated experience managing regulatory authority and auditing body interactions, including pre-submissions, interactive reviews, and supporting regulatory audits/inspections (such as MDSAP surveillance audits, FDA inspections, and Notified Body audits).

· Exceptional analytical, technical writing, and communication skills, with the ability to translate complex software and clinical concepts into clear regulatory arguments for various stakeholders.

· Entrepreneurial mindset with a passion for innovation, comfortable navigating fast-paced, ambiguous startup environments, and working within a matrixed, cross-functional organization.

· This role is remote but does require 10% to 15% domestic travel.

Preferred Qualifications:

· Advanced degree (MS, PhD, or MBA) in a relevant scientific, engineering, or regulatory discipline.

· Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) or equivalent professional credential.

· Experience with AI/ML-enabled medical devices, including familiarity with FDA's AI/ML software guidance, Predetermined Change Control Plans (PCCP), and algorithm change protocols.

· Experience preparing, submitting, and managing PMA (Premarket Approval) applications and IDEs (Investigational Device Exemptions) for Class III medical devices.

· Experience in cardiovascular diagnostics, ECG analysis, or digital health platforms.

· Experience in early-stage or high-growth digital health startups, with a proven ability to build regulatory infrastructure and scalable processes.

· Familiarity with agile software development methodologies.

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. xhyhwjd 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.