At a Glance
- Tasks: Lead regulatory affairs for innovative diagnostics and manage performance study applications.
- Company: Global biotechnology leader at the forefront of medical innovation.
- Benefits: Competitive salary, hybrid work options, and a chance to impact healthcare.
- Other info: Contract role with excellent career growth in a collaborative environment.
- Why this job: Join a dynamic team driving the future of diagnostics and therapeutics.
- Qualifications: 5+ years in pharma/diagnostics with IVD regulatory experience required.
The predicted salary is between 60000 - 76000 £ per year.
Job Type: Maternity Cover – 12 Month Contract
Location: West London, UK – Hybrid/Remote
Salary: £60,000 - £76,000
Please note that this is a contract opportunity.
Cpl Life Sciences is partnering with a global leading biotechnology business at the heart of innovation. This role is sitting at the interface of therapeutics and diagnostics, helping bring biomarker-driven medicines to market through companion diagnostic and IVD regulatory strategy.
The Temporary Manager, Regulatory Affairs IVD will provide project management support for performance studies applications and performance study notifications. This role will partner with clinical study teams, site start-up teams, and performance study sponsors to facilitate on-time clinical trials.
The temporary Manager, Regulatory Affairs IVD will be responsible for planning, coordinating, tracking and driving execution of performance study applications and performance study notifications activities in accordance with EU IVDR.
Essential Functions required for the job:
- Lead operational planning of IVD performance study notifications/applications activities.
- Coordinate cross-functional activities required for performance study notifications/applications milestones, trackers, requests for information, and risk mitigation plans.
- Ensure timely responses to regulatory authority requests for information.
- Facilitate communication between performance study sponsors, clinical study teams and regulatory stakeholders.
- Track country-specific submission requirements and maintain submission status trackers.
- Contribute to continuous improvement focused on submission planning, tracking and operational efficiency.
Job Requirements:
Minimal Requirements:
- Bachelor's degree in Life Sciences, Engineering or a related technical field.
- 5+ years’ pharmaceutical or diagnostics industry experience, including 1-2 years IVD/Medical Device Regulatory Affairs experience.
- Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA).
- Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs.
- Excellent written and verbal communication skills.
Preferred Requirements:
- Advanced degree (Master's and above).
- Experience with companion diagnostic development processes and regulatory filings.
Please note this role is a contract role paying a fixed salary and requires someone to be based in the UK or Ireland. You must be comfortable with hybrid working and be on no more than a 4-week notice period.
Regulatory Affairs Manager - IVDs in London employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the vibrant streaming and entertainment sector. Employees benefit from immediate project impact opportunities, comprehensive training, and career growth in a cloud-oriented environment, making it an ideal place for those looking to advance their skills in data engineering while working with cutting-edge technologies.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager - IVDs in London
✨Join Biotechnology Meetups
Get yourself into the loop by joining local biotech meetups or workshops. These events are perfect for making connections with professionals in the field and can often lead to temporary gigs through word-of-mouth. Plus, you'll get to hear about the latest trends and developments directly from the source.
✨Showcase Your Passion in Science
Consider starting a blog or social media channel to showcase your interest in biotechnology. Share the latest research, your insights, and even your projects. This will not only enhance your visibility in the community but also attract potential employers like Cpl Life Sciences who might be scrolling through for talent.
✨Tap into University Resources
If you’re still in school or recently graduated, don’t forget to use your university’s career services. They often have exclusive connections with companies looking for temporary staff. Reach out to them for internship listings and networking opportunities tailored to the biotech sector.
✨Apply Directly on Our Website
When you spot that perfect temporary role at Cpl Life Sciences, make sure to apply directly through our website. This way, you’ll be in the best position to get noticed quickly and can show your enthusiasm for the role while filling out the application.
We think you need these skills to ace Regulatory Affairs Manager - IVDs in London
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to Cpl Life Sciences as a temporary teammate.
Highlight Your Research Experience:If you’ve worked on any research projects — whether during your studies or in previous positions — make sure to detail these in your application. Include the objective, your role, and what you achieved. This will help us see your potential and fit for the temporary position at Cpl Life Sciences.
Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at Cpl Life Sciences. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at Cpl Life Sciences.
How to prepare for a job interview at Cpl Life Sciences
✨Brush Up on Your Biotech Basics
Understanding the fundamental concepts in biotechnology is crucial. Be ready to discuss core topics like genetics, molecular biology, or bioinformatics, especially if you're asked technical questions. We suggest revisiting your coursework or recent projects to refresh your memory.
✨Demonstrate Your Adaptability
Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
✨Be Prepared to Explain Your Passion
Hiring managers want to see your motivation, especially for a temporary position in a fast-paced field like biotechnology. Be ready to discuss what excites you about the industry, your career goals, and how this role at Cpl Life Sciences aligns with them. It’s all about showing that you’re not just looking for a job, but a stepping stone in your biotech journey.
