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 opportunities to work on cutting-edge inhalation technologies.
- 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 Slough 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 within our supportive culture. Located in a vibrant area, we provide competitive benefits and a chance to make a meaningful impact on healthcare through your expertise in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Consultant (Medical Devices) in Slough
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Planet Pharma looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Consultant (Medical Devices) in Slough
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Planet Pharma. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Planet Pharma
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Planet Pharma’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
