At a Glance
- Tasks: Lead regulatory strategies for innovative medical devices and ensure compliance with FDA standards.
- Company: Dynamic company focused on advancing healthcare through combination products.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative environment with opportunities to lead and innovate.
- Why this job: Make a real impact in the medical field while working on cutting-edge technology.
- Qualifications: Experience in regulatory affairs and strong knowledge of inhalation products required.
The predicted salary is between 60000 - 80000 £ per year.
The Regulatory Consultant will provide high‑level regulatory leadership for a combination pharmaceutical product comprising a control and closure system with a device component. This role is critical to ensuring the successful update and maintenance of the Device Master File (DMF) and supporting a US NDA submission with a firm deadline in February. Deep expertise in combination product regulations, design control, risk management, and inhalation technologies is essential.
Key Responsibilities
- Device Master File Management — Lead updates, gap assessments, and alignment of the DMF for the control and closure system, ensuring compliance with FDA expectations for device components within combination products.
- Combination Product Regulatory Strategy — Provide authoritative guidance on 21 CFR Part 4, combination product pathways, and cross‑functional regulatory requirements.
- Inhalation Product Expertise — Apply inhalation-specific regulatory knowledge to ensure the device component and drug‑device interface meet performance, safety, and quality standards.
- NDA Support — Drive dossier delivery for the US NDA, coordinating module content, timelines, and cross-functional inputs to meet the February submission deadline.
- Design Control Leadership — Oversee design history file elements, design verification/validation alignment, and documentation readiness for regulatory review.
- Risk Management — Ensure risk management activities (per ISO 14971) are robust, traceable, and integrated across drug and device components.
- Stakeholder Management — Partner with engineering, quality, regulatory, and clinical teams to ensure cohesive and compliant documentation.
- Regulatory Authoring & Review — Draft, review, and refine regulatory documents, ensuring clarity, consistency, and alignment with FDA expectations.
- Project Leadership — Manage timelines, risks, and deliverables with the authority expected at PM, Associate Director, or Director level.
Required Experience & Qualifications
- Proven experience in combination product regulatory affairs (essential).
- Strong background in inhalation products, ideally with device‑drug interface experience.
- Demonstrated success supporting US NDA submissions, including Module 3 and device‑related content.
- Expertise in design control, risk management, and device documentation systems.
- Experience managing Device Master Files or similar device regulatory documentation.
- Ability to operate at a senior level (PM, Associate Director, or Director) with strategic and hands‑on capability.
- Excellent communication, cross-functional leadership, and regulatory problem‑solving skills.
Regulatory Consultant (Medical Devices) in City of London employer: Planet Pharma
As a leading employer in the medical device sector, we offer our Regulatory Consultants a dynamic work environment that fosters innovation and collaboration. Our commitment to employee growth is evident through continuous training opportunities and a supportive culture that values expertise in combination products and inhalation technologies. Located in a vibrant area, we provide a unique chance to contribute to impactful projects while enjoying a balanced work-life experience.
