Director, Device, Global Regulatory Affairs
Location
United States
Posted
5 days ago
Salary
Not specified
No structured requirement data.
Job Description
Job Summary
The Director, Device, Global Regulatory Affairs is responsible for developing and leading global regulatory strategies for the device component of drug-device combination products. This position works with the technical and device strategy team to ensure the device development, verification, validation, and manufacturing activities meet the regulatory requirements in compliance with combination product frameworks (ie 21 CFR Part 4, ISO 13485, EU MDR). The Director provides regulatory leadership across device quality, engineering, human factors, and commercial readiness activities while serving as a key interface with global health authorities and Liquidia’s device manufacturing partners on health authority and device-related topics.
Education and Experience
- Bachelor’s degree in life sciences, engineering, chemistry, biochemistry, or related field. Advanced degree preferred. RAC or similar certification a plus.
- Approximately 12 years of device and combination product regulatory or related experience in the pharmaceutical industry with device regulatory leadership in biotech or pharmaceuticals. Strong preference for experience with inhalation drug-device combination products.
- Experience global device regulations, including FDA 21 CFR Parts 4, 820, 801, 803, EU MDR/IVDR, and ISO 13485/14971.
- Demonstrated success leading device regulatory submissions and interactions with device-focused regulatory authorities.
- Strong knowledge and experience of drug and device development and life cycle management concepts and interdependencies with the overall development process.
- Strong understanding of device classification, regulatory pathways, and global device frameworks (PMA, 510(k), Technical Files, CE marking).
- Deep knowledge of design controls, risk management, usability engineering, and device quality system requirements.
- Familiarity with combination product interfaces, including CMC integration and biologic/device development dependencies.
- Working knowledge of global CMC regulatory requirements, ICH guidelines, and technical development considerations.
- Ability to provide strategic guidance to cross-functional teams and external vendors.
- Strong interpersonal, negotiation, and communication skills with experience presenting to regulators and senior leadership.
- Proven ability to lead in a matrix environment while managing multiple programs simultaneously
- Demonstrated aptitude for ‘hands-on’ troubleshooting and problem solving with an exemplary history as a “self-starter”.
- Strong desire to work as part of many cross-functional teams consisting of technical, quality, clinical, and administrative team members.
- Unrelenting dedication to defining strategies to support business objectives and delivering high quality results.
- Occasional travel required (<10%).
- Develops and implements global regulatory strategies for the medical device component of the drug-device combination in conjunction with the regulatory team member and other SMEs supporting clinical development and commercialization.
- Leads preparation of high-quality Module 2 and Module 3 documentation for INDs, CTAs, BLAs, MAAs, and lifecycle submissions. This includes IMPDs, annual reports, and post-approval changes.
- Provides input into design dossiers/technical files (i.e. design history file).
- Supports regulatory strategies for applicability of device standards and guidance for the device component of the combination product for manufacturing changes, comparability protocols, and post-approval commitments.
- Serves as the primary device regulatory subject matter expert during interactions with the FDA, EMA, and other global health authorities.
- Supports responses to health authority questions, specific advice, and regulatory intelligence monitoring.
- Collaborates closely with Device Strategy, Manufacturing, CMC, Quality, Clinical Development, technical team members, device partners, and vendors to align development and post-marketing activities with global regulatory requirements for filings and maintenance.
- Ensures combination product design control activities meet regulatory expectations, including user needs, risk management (ISO 14971), design verification/validation, and DHF/DMR/Technical File readiness.
- Supports human factor programs, including study design, protocol review, and regulatory alignment for HF validation studies.
- Guides regulatory requirements to combination product cGMP compliance under 21 CFR Part 4.
- Leads, authors, and reviews device related documents for health authority filings such as device sections of Module 3, Device Master File components (as applicable). Provides input and review to DHF/Technical File summaries, and human factor engineering reports.
- Reviews applicable CMC sections of regulatory submissions (NDA/MAA and supplements, IND/CTA, reports or correspondences, annual reports, IND/CTA amendments) and ensures compliance with regulations and standards of health authorities around the world for assigned programs.
- Prepares responses to regulatory authority information requests during the review process to support application approval and maintenance.
- Supports teams for health authority meetings.
- Collaborates with Quality Assurance to ensure device quality system alignment with ISO 13485 and region-specific requirements.
- Supports audits, inspections, and readiness activities for device and combination product components.
- Participates in developing internal standards, SOPs, and templates for device regulatory activities.
Related Guides
Related Categories
Related Job Pages
More Director Jobs
Sales Director
HiBobHiBob helps modern, mid-size businesses transform the way they manage people, giving HR and managers all they need to connect, engage, develop, and retain top talent. Since 2015, we’ve achieved consecutive triple-digit year-over-year growth, all backed by our amazing team of Bobbers from across the globe, making us the choice HRIS of over 4000 midsize and multinational companies. Our HR platform is intuitive, data-driven, and built for the way people work today: globally, remotely, and collaboratively. Fast-growing companies across the globe such as Huel, What3words, Fiverr, and VaynerMedia rely upon Bob to help them create the best work experiences for their people.
The Sales Director will be a strategic leader responsible for growing the book of business with new logos by managing and developing the Sales Team reporting to the VP of Sales. Key duties include achieving annual sales quotas, managing Account Executive performance, providing accurate forecasts, and developing regional pipeline growth strategies.
This senior leadership role oversees enterprise IT operations, security, and governance across a multi-business-unit portfolio, combining hands-on IT leadership with formal Governance, Risk, and Compliance (GRC) ownership. Key duties include defining and executing IT strategy, enforcing governance frameworks aligned with standards like CIS v8 and ISO 27001, and supporting M&A activities through due diligence and integration planning.
The Senior Director IGEL Community is tasked with building and growing a global community around IGEL OS and EUC technologies, acting as a central connector between users, partners, and internal teams. Key duties involve driving engagement, facilitating knowledge sharing, creating high-value content, and managing community programs and metrics.
The Director is accountable for end-to-end service delivery performance, ensuring SLAs are met, and overseeing prioritization and coordination of work across projects and support activities. Key duties include owning the service delivery cost base, managing budgets, and contributing to P&L performance.
