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- Tasks: Support regulatory affairs for innovative drug-device combination projects and collaborate with development teams.
- Company: Join a global leader in combination devices, working remotely with a dynamic team.
- Benefits: Competitive hourly rate, flexible remote work, and potential for contract extension.
- Other info: Work UK hours in a fast-paced environment with opportunities for professional growth.
- Why this job: Make a real impact in the medical device industry while advancing your regulatory expertise.
- Qualifications: Bachelor's degree in a relevant field and experience in regulatory affairs.
The predicted salary is between 50 - 70 £ per hour.
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. The 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.
QUALIFICATIONS / SKILLS:
- 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 in Wolverhampton employer: LennTech Search
Contact Detail:
LennTech Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Wolverhampton
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field. Attend industry events or webinars, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of CMC and device requirements. We recommend creating a cheat sheet of key regulations and guidelines relevant to drug-device combination products. This will help you feel confident and ready to impress!
✨Tip Number 3
Showcase your experience with specific examples during interviews. We want to hear about your past projects and how you’ve navigated regulatory challenges. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them memorable.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged. So, get your application in and let’s get the conversation started!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Wolverhampton
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 skills align with the key duties mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past work that relate to the responsibilities outlined, and don’t forget to express your enthusiasm for joining our team!
Showcase Relevant Experience: When filling out your application, emphasise your experience with CMC and device requirements. We’re looking for someone who can hit the ground running, so make it clear how your background prepares you for this role.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it makes the process smoother for everyone involved!
How to prepare for a job interview at LennTech Search
✨Know Your Stuff
Make sure you brush up on the latest regulations and guidelines related to drug-device combination products. Familiarise yourself with CMC requirements and be ready to discuss how your experience aligns with the key duties outlined in the job description.
✨Showcase Your Experience
Prepare specific examples from your past roles that demonstrate your expertise in regulatory affairs, especially in device development and CMC support. Use the STAR method (Situation, Task, Action, Result) to structure your responses and make them impactful.
✨Ask Smart Questions
Come prepared with insightful questions about the company's regulatory processes and challenges they face. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.
✨Be Ready for Technical Discussions
Expect to dive deep into technical topics during the interview. Brush up on device verification, validation documents, and risk management strategies. Being able to discuss these confidently will set you apart from other candidates.