At a Glance
- Tasks: Lead regulatory strategies for innovative medical devices and ensure compliance with FDA standards.
- Company: Dynamic company at the forefront of medical device innovation.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and career advancement.
- Why this job: Make a real impact in healthcare by ensuring the safety and efficacy of combination products.
- Qualifications: Experience in regulatory affairs for combination products and strong communication skills.
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 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 tailored training programmes and opportunities for advancement, all while working in a location that prioritises work-life balance and community engagement. Join us to be part of a team that values your expertise and supports your professional journey in making a meaningful impact on healthcare.
