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- Tasks: Support regulatory affairs for innovative drug-device combination projects and ensure compliance with regulations.
- Company: Join a global leader in combination devices with a focus on innovation.
- Benefits: Competitive hourly rate, remote work, and potential for contract extension.
- Other info: Work UK hours in a dynamic environment with opportunities for professional growth.
- Why this job: Make a real impact in the medical device industry while working on cutting-edge projects.
- Qualifications: Bachelor’s degree in a relevant field and experience in regulatory affairs.
The predicted salary is between 50 - 70 £ per hour.
Regulatory Affairs Senior (Remote / Inside IR35 & Hourly Rate) LennTech are supporting a global combination devices client who have a need for a Senior Regulatory Affairs professional to come on board for an initial six-month hourly rate contract with a view to extending.
Person will be experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements.
KEY DUTIES:- Regulatory support to Device Development (DD) team and activities e.g. final review, comment and approval of existing device-related technical documentation including device verification and validation documents, device specifications, risk management, human factors, biological evaluation, device labelling, IFU/QRG, End of Phase review and advising on interpretation of legislation/guidance, attending internal device development meetings.
- Regulatory CMC support to Pharmaceutical Development (PD) team e.g. final review, comment and approval of pharm dev protocols and reports (pharm dev and stability), SPECs (bulk, final product, per strength), justifications of specs, shelf life justifications, QTPP, batch manufacture documents, Product History File, Technical Risk Assessments, Product Specification File, Product Specification Index, QTAs, labelling and packaging text, advising on interpretation of legislation/guidance, attending internal CMC meetings.
- Review of CCRs raised by other functions (e.g. assessment of impact on regulatory submissions and approval of CCRs).
- Review of Device and CMC related information in Clinical Documents: Clinical Protocol, Pharmacy Manual, Investigator’s Brochure.
- Reviewing and supporting CMC and Device sections of the Clinical Trial Notification in Australia.
- Bachelor’s Degree (or higher) in a relevant scientific or engineering field.
- Experience in regulatory affairs within the medical device, CMC or Drug-Device combination product industry, preferably from pharmaceutical industry or from a regulatory agency.
- Demonstrated understanding of and ability to interpret regulations and guidelines governing pharmaceutical products and medical devices.
- Strong knowledge of regulatory submission processes and global regulatory frameworks.
Please note this role will be UK hours. Feel free to reach out and discuss further.
Senior Regulatory Affairs Specialist employer: LennTech Search
Contact Detail:
LennTech Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with drug-device combination products. A friendly chat can lead to insider info about job openings that might not be advertised.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CMC and device requirements. Be ready to discuss specific projects you've worked on and how you navigated regulatory challenges. We want to see your expertise shine!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply through our website for the best chance at landing that Senior Regulatory Affairs Specialist role. We’re always on the lookout for talented individuals like you, so make sure your application stands out!
We think you need these skills to ace Senior Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in regulatory affairs, especially with drug-device combination products. We want to see how your background aligns with the key duties mentioned in the job description.
Showcase Relevant Experience: In your cover letter, emphasise your experience supporting development projects and your knowledge of CMC and device requirements. We love seeing specific examples that demonstrate your expertise!
Be Clear and Concise: When writing your application, keep it clear and to the point. We appreciate well-structured documents that make it easy for us to see your qualifications and fit for the role.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at LennTech Search
✨Know Your Regulations
Make sure you brush up on the latest regulations and guidelines governing pharmaceutical products and medical devices. Being able to discuss specific legislation and how it applies to drug-device combination products will show that you're not just familiar with the basics, but that you’re truly engaged with the field.
✨Showcase Your Experience
Prepare to discuss your previous roles in regulatory affairs, especially any experience with CMC and device-related documentation. Use specific examples from your past work to illustrate how you've successfully navigated complex regulatory challenges, as this will demonstrate your capability to handle the responsibilities of the role.
✨Engage with the Team
Since this role involves attending internal meetings, be ready to talk about how you collaborate with cross-functional teams. Highlight your communication skills and how you’ve contributed to team success in previous projects, particularly in device development and CMC support.
✨Ask Insightful Questions
Prepare a few thoughtful questions about the company’s current projects or challenges they face in regulatory affairs. This shows your genuine interest in the role and helps you assess if the company is the right fit for you. Plus, it gives you a chance to demonstrate your knowledge of the industry.