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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 Swindon 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 Swindon
✨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. 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 just apply anywhere; focus on companies that align with your expertise in medical devices and pharmaceuticals. Use our website to find roles that match your skills and interests, making your application stand out.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can leave a lasting impression. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Senior Regulatory Affairs Specialist in Swindon
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 sure we see your relevant achievements front and centre.
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 this exciting opportunity. Plus, it’s super easy!
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.
✨Prepare Real-Life Examples
Think of specific projects you've worked on that relate to device verification, validation documents, or regulatory submissions. Be prepared to share these examples during the interview to demonstrate your hands-on experience and problem-solving skills.
✨Understand the Company’s Needs
Research LennTech and their focus on combination devices. Understanding their products and challenges will help you tailor your responses and show that you're genuinely interested in contributing to their team.
✨Ask Insightful Questions
Prepare thoughtful questions about the role, team dynamics, and upcoming projects. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.