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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 flexibility, 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.
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 Leicester 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 Leicester
✨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 or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CMC and device requirements. We recommend creating a list of key regulations and guidelines that are relevant to the role, so you can confidently discuss them during your interview.
✨Tip Number 3
Showcase your expertise! During interviews, be ready to share specific examples of how you've supported development projects in the past. Highlight your experience with technical documentation and regulatory submissions to impress the hiring team.
✨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 take the initiative to connect directly with us.
We think you need these skills to ace Senior Regulatory Affairs Specialist in Leicester
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 fits perfectly with what we're looking for!
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 how you can contribute to our team!
Showcase Relevant Experience: When filling out your application, be sure to showcase your experience in regulatory affairs, especially in the medical device sector. Include details about your involvement in regulatory submissions and any meetings you've attended that relate to device development or CMC.
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 get all the updates directly from us. Plus, it shows you're keen on joining our team at StudySmarter!
How to prepare for a job interview at LennTech Search
✨Know Your Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially around drug-device combination products. Familiarise yourself with the specific regulations and guidelines that govern these areas, as well as any recent changes in legislation. This will show that you're not just experienced but also up-to-date.
✨Prepare for Technical Questions
Expect to be asked about your experience with device verification, validation documents, and CMC processes. Prepare specific examples from your past work where you successfully navigated these challenges. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Show Your Team Spirit
This role involves collaboration with various teams, so be ready to discuss how you've worked effectively with others in the past. Highlight your experience attending internal meetings and how you contributed to discussions, especially regarding regulatory support and compliance.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire 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.