At a Glance
- Tasks: Assess medical devices and AI products, guiding teams on regulatory compliance.
- Company: Join a leading healthcare transformation consultancy based in London.
- Benefits: Negotiable day rate, flexible remote work, and potential for contract extension.
- Other info: Work with diverse teams and enhance your expertise in a dynamic environment.
- Why this job: Make a real impact in the evolving field of medical devices and digital health.
- Qualifications: Experience in regulatory affairs and understanding of medical device frameworks required.
Seniority: Consultant - Expert
Day rate: Negotiable and outside IR35
Project duration: 3 months (potential to extend), starting in June
Location: 2 days on-site in London, 3 days remote
We’re supporting a healthcare transformation consultancy, headquartered in London. They're seeking regulatory specialists with experience across life sciences and medical devices, ideally with exposure to SaMD (Software as a Medical Device) and AI. The role will support the assessment of medical device products from a regulatory, risk and classification perspective, helping clients navigate relevant requirements across key markets.
Tasks
- Assess medical device and SaMD / AI products from a regulatory, risk and classification perspective
- Support the interpretation of relevant regulatory requirements across markets such as the UK, EU and US
- Provide practical guidance to project teams on regulatory considerations, documentation and compliance pathways
Requirements
- An independent consultant
- Experience in regulatory affairs within life sciences, medical devices, SaMD or digital health
- Understanding of medical device classification, risk assessment and regulatory frameworks, ideally including MHRA, EMA / EU MDR and FDA
- Ability to work with both technical and non-technical stakeholders, translating regulatory requirements into clear, practical advice
Regulatory Specialist (Medical Devices) - Contract role in London employer: Project Blackbook
As a leading healthcare transformation consultancy based in London, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to thrive. With flexible working arrangements that include both on-site and remote opportunities, we offer competitive day rates and the chance to work on impactful projects within the life sciences sector. Our commitment to professional development ensures that you will have access to growth opportunities while contributing to meaningful advancements in medical device regulation.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist (Medical Devices) - Contract role in London
✨Get Your Portfolio Ready
When it comes to compliance and risk, a solid portfolio is crucial. Showcase your past work, particularly any interesting case studies or projects that relate to regulations or risk management. This not only demonstrates your expertise but also helps you stand out to potential clients.
✨Join Compliance Networks
In the compliance-risk world, connecting with industry professionals can be a game-changer. Join associations like the Association of Certified Compliance Professionals or attend events focused on regulatory changes. These are great places to meet potential clients and learn about freelance opportunities.
✨Utilise Online Freelance Platforms
Platforms like Upwork or Freelancer can be goldmines for freelance compliance work. Keep an eye out for jobs that require specific compliance skills, and don’t hesitate to pitch your expertise. Make your profile shine with relevant certifications and experiences.
✨Tap Into Our Community
Check out our opportunities on the StudySmarter site! We often post freelance roles that could be right up your alley. Don’t miss out on applying directly through us, as we want to support you in landing your dream freelance compliance gig!
We think you need these skills to ace Regulatory Specialist (Medical Devices) - Contract role in London
Some tips for your application 🫡
Show Off Your Compliance Expertise:In the compliance-risk field, it's crucial to highlight your knowledge of regulations and risk management frameworks. Make sure your CV showcases relevant certifications like CISA or CISM, and any experience with compliance audits. This will demonstrate your capability to navigate the complexities of compliance effectively.
Build a Strong Portfolio:As a freelancer, your portfolio is your best friend! Include case studies of past compliance projects, detailing the challenges faced and the solutions you implemented. Potential clients at Project Blackbook will love seeing the tangible impact of your work and your analytical skills in action.
Tailor Your Application:When applying to Project Blackbook, deep dive into their specific compliance needs. Research their industry and mention how your unique skill set can address their challenges. A personalised touch can go a long way in freelance applications, showing you’re not just sending out a generic CV.
Discuss Your Availability and Rates:In your application, it's essential to be upfront about your availability and rates. Freelance work often involves negotiating terms, so outlining what you can offer and your expected compensation will save time and set clear expectations from the start.
How to prepare for a job interview at Project Blackbook
✨Showcase Your Compliance Knowledge
In the freelance compliance-risk world, it's crucial to highlight your understanding of regulations and frameworks relevant to the industry. During your chat with Project Blackbook, be ready to discuss specific laws that impact their operations and show how your previous projects tackle compliance challenges.
✨Prepare Your Portfolio of Solutions
As a freelancer, your portfolio is your golden ticket! Have examples ready that demonstrate your ability to identify and mitigate risks, complete with case studies from past gigs. This will help you illustrate your hands-on experience and problem-solving skills effectively to Project Blackbook.
✨Be Ready for Scenario Questions
Expect the interviewers at Project Blackbook to throw some scenario-based questions your way. They might ask how you'd approach a particular risk situation or compliance issue. Think through some real-life examples or hypothetical situations beforehand to display your analytical skills and risk-assessment strategies.
✨Discuss Your Flexibility and Approach to Projects
As a freelancer, it’s key to convey how you adapt to different clients and workflows. Talk to Project Blackbook about your past experiences working independently and how you structure your projects, demonstrating your professionalism and ability to meet deadlines without micromanagement.
