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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, working remotely with a dynamic team.
- Benefits: Competitive hourly rate, flexible remote work, and potential for contract extension.
- Other info: Collaborative environment with opportunities for professional growth and development.
- 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 Lincoln 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 Lincoln
✨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 even 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 who knows their stuff.
✨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, and applying directly can give you an edge over other candidates!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Lincoln
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, like your experience with CMC and device requirements.
Showcase Relevant Qualifications: Don’t forget to mention your qualifications! If you have a Bachelor’s Degree or higher in a relevant field, make it stand out. We love seeing candidates who have a solid educational background in science or engineering.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
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 clearly.
✨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 submissions and approvals.
✨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 gauge if it’s the right fit for you.