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 hours, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and career advancement.
- Why this job: Make a real difference in healthcare by ensuring the safety and efficacy of combination products.
- Qualifications: Expertise in regulatory affairs, particularly in combination products and inhalation technologies.
The predicted salary is between 60000 - 80000 £ per year.
Role Summary
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
Regulatory Consultant (Medical Devices) employer: Planet Pharma
As a leading player in the medical devices sector, our company offers an exceptional work environment that fosters innovation and collaboration. Employees benefit from a strong focus on professional development, with opportunities to enhance their expertise in regulatory affairs while working alongside industry experts. Located in a vibrant area, we promote a healthy work-life balance and provide competitive benefits, making us an attractive employer for those seeking meaningful and rewarding careers in regulatory consulting.
