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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: 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 40 - 50 £ 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.
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.
- 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.
Regulatory Specialist and Senior Specialist employer: LennTech Search
Contact Detail:
LennTech Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist and Senior Specialist
✨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 referrals.
✨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, and tailor your approach accordingly.
✨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 Regulatory Specialist and Senior Specialist
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 background aligns with the key duties mentioned in the job description.
Showcase Relevant Experience: In your cover letter, emphasise your experience supporting development projects and your knowledge of CMC and device requirements. We love seeing specific examples that demonstrate your expertise!
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read through your qualifications and experiences quickly.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at LennTech Search
✨Know Your Regulations
Make sure you brush up on the latest regulations and guidelines governing pharmaceutical products and medical devices. Being able to discuss specific regulations during your interview will show that you’re not just familiar with the field, but that you’re also proactive in keeping your knowledge current.
✨Showcase Relevant Experience
Prepare to discuss your previous experience with drug-device combination products and CMC requirements. Use specific examples from your past roles to illustrate how you've successfully navigated regulatory challenges and contributed to development projects.
✨Understand the Company’s Needs
Research LennTech and their focus on combination devices. Tailor your responses to demonstrate how your skills and experiences align with their specific needs, especially in supporting device development and CMC activities.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the team dynamics. This not only shows your interest in the position but also gives you a chance to assess if the company culture and expectations align with your career goals.