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- Tasks: Support regulatory affairs for innovative drug-device combination projects and ensure compliance.
- 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: Collaborative environment with opportunities to grow your expertise in regulatory processes.
- Why this job: Make a real impact in the medical device industry while working from anywhere.
- 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 Worcester 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 Worcester
✨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 yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CMC and device requirements. We recommend creating a list of common interview questions related to regulatory affairs and practising your answers. Confidence is key!
✨Tip Number 3
Don’t forget to showcase your experience with technical documentation during interviews. Bring examples of your work or discuss specific projects where you provided regulatory support. This will help you stand out as a candidate.
✨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 shines!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Worcester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your experience with drug-device combination products and any relevant regulatory frameworks you've worked with. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific projects you've worked on that relate to device development and CMC support. Let us know what makes you tick!
Showcase Your Knowledge: In your application, don't shy away from showcasing your understanding of regulations and guidelines. We love candidates who can interpret complex legislation and provide insights into regulatory submissions. Make it clear that you know your stuff!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates. Plus, it’s super easy – just a few clicks and you’re done!
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 highlight your contributions.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the company and the role. Inquire about their current projects, challenges they face in regulatory affairs, or how they approach compliance with evolving regulations. This shows you're engaged and thinking critically about the position.
✨Be Ready for Technical Discussions
Since this role involves reviewing technical documentation and attending internal meetings, be prepared to discuss your approach to evaluating device specifications, risk management, and labelling. Brush up on relevant terminology and be ready to explain your thought process clearly.