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- Tasks: Join us as a Regulatory Affairs Advisor, ensuring our MedTech products meet all regulations.
- Company: We're a dynamic MedTech company based in Henley-on-Thames, focused on innovation and compliance.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Be a key player in shaping medical device regulations while working closely with leadership.
- Qualifications: Experience in Regulatory Affairs within MedTech is essential; knowledge of UKCA, MHRA, and FDA is a must.
- Other info: Ideal candidates will have a degree or master's in a relevant field and a passion for compliance.
The predicted salary is between 36000 - 60000 £ per year.
A MedTech business based in Henley-on-Thames are looking to hire a specialist Regulatory Affairs Advisor to play a key role in ensuring the businesses products comply with national and international regulatory requirements. This role is vital to the business and team and will work closely with the Managing Directors. The role will have a wide variety of responsibilities and day to day duties, some included are: Executing regulatory strategies for new as well as existing medical devices keeping in line with UK & international standards Submitting regulation filings to the relevant bodies Being the main point of contact for all aspects of regulation work Pulling together clinical support data & analysis Post market performance analysis work Labelling & documentation work Tender management & submissions Providing training & support to other internal members With the importance of this position the business is seeking candidates with the following experience: Career experience within Regulatory Affairs in the MedTech / Life Sciences industry Medical devices focussed background Must have excellent knowledge of UKCA marking, MHRA, EU MDR, and FDA regulatory requirements. Must have excellent understanding of ISO 13485, ISO 14971, and relevant quality management systems. Preferable education to degree or masters level in a suppo…
Regulatory Affairs Advisor - MedTech employer: DBCharles Recruitment Limited
Contact Detail:
DBCharles Recruitment Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Advisor - MedTech
✨Tip Number 1
Familiarize yourself with the latest UKCA marking, MHRA, EU MDR, and FDA regulatory requirements. Staying updated on these regulations will not only boost your confidence during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the MedTech and Life Sciences industry. Attend relevant conferences or webinars where you can meet people who work in Regulatory Affairs. This can lead to valuable connections and insights that may help you stand out.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your knowledge of ISO 13485 and ISO 14971. Being able to articulate how you've applied these standards in real-world scenarios will make a strong impression.
✨Tip Number 4
Research the company’s products and their current regulatory status. Understanding their portfolio will allow you to tailor your discussions and show how your expertise can directly benefit their operations.
We think you need these skills to ace Regulatory Affairs Advisor - MedTech
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements. Tailor your application to highlight your relevant experience in Regulatory Affairs, especially in the MedTech sector.
Highlight Relevant Experience: In your CV and cover letter, emphasize your career experience within Regulatory Affairs, particularly with medical devices. Mention specific projects or roles where you executed regulatory strategies or submitted regulation filings.
Showcase Your Knowledge: Demonstrate your understanding of UKCA marking, MHRA, EU MDR, and FDA regulatory requirements in your application. Include any certifications or training that support your expertise in these areas.
Prepare a Strong Cover Letter: Craft a compelling cover letter that not only outlines your qualifications but also conveys your passion for the MedTech industry. Discuss how your skills align with the company's goals and how you can contribute to their success.
How to prepare for a job interview at DBCharles Recruitment Limited
✨Know Your Regulations
Make sure you have a solid understanding of UKCA marking, MHRA, EU MDR, and FDA regulatory requirements. Be prepared to discuss how these regulations impact the MedTech industry and your previous experiences with them.
✨Showcase Your Experience
Highlight your career experience within Regulatory Affairs, especially in the MedTech or Life Sciences sectors. Prepare specific examples of how you've successfully navigated regulatory challenges in the past.
✨Demonstrate Analytical Skills
Since the role involves pulling together clinical support data and post-market performance analysis, be ready to discuss your analytical skills. Share examples of how you've used data to inform regulatory strategies or decisions.
✨Prepare for Team Collaboration
This position requires working closely with Managing Directors and other team members. Think about how you've effectively collaborated in the past and be ready to share those experiences during the interview.
