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- Tasks: Lead regulatory compliance for groundbreaking cancer diagnostic technology.
- Company: Join a world-leading biotech firm revolutionizing cancer diagnostics with liquid biopsy technology.
- Benefits: Be part of a pioneering team with global expansion opportunities and innovative projects.
- Why this job: Make a significant impact in cancer diagnostics while shaping the future of personalized medicine.
- Qualifications: Experience in IVD medical device development and knowledge of FDA regulations required.
- Other info: This role is based in Guildford, offering a chance to influence global product rollout.
The predicted salary is between 43200 - 72000 £ per year.
Head of Regulatory Affairs THE COMPANY Our client, a world-leading biotech company, is at the forefront of liquid biopsy technology. They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine. Their groundbreaking system, the first FDA-cleared device of its kind, enables the collection and analysis of intact circulating cancer cells, offering new insights into metastatic disease. The company operates a UK-based Clinical Laboratory in Guildford and is expanding its services globally, integrating advanced molecular profiling techniques such as digital PCR and NGS. THE ROLE We are seeking an experienced Head of Regulatory Affairs to join our client’s team in Guildford. In this key leadership role, you will act as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets. You will provide strategic direction and operational oversight to the regulatory and quality teams, managing compliance with international medical device directives and regulations, including ISO13485 and ISO15189. You will play an essential role in new product development (NPD) by defining regulatory strategies, guiding clinical and analytical validation studies, and liaising with regulatory authorities. This position offers the opportunity to influence the global commercial rollout of a revolutionary cancer diagnostic technology. ABOUT YOU The ideal candidate will possess: Experience in IVD medical device product development, adhering to standards such as ISO14971. In-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards. HOW TO APPLY If you are an experienced regulatory professional with a passion for innovation in cancer diagnostics, this is an exciting opportunity to make a significant impact. If this sounds like the right opportunity for you, apply here or email tyler@singulartalent.io for more information.
Head of Regulatory Affairs employer: Singular: Building Brilliant Biotechs
Contact Detail:
Singular: Building Brilliant Biotechs Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs
✨Tip Number 1
Familiarize yourself with the latest FDA regulations and MEDDEV guidelines. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to regulatory compliance in the biotech field.
✨Tip Number 2
Network with professionals in the regulatory affairs space, especially those who have experience with IVD medical devices. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest advancements in liquid biopsy technology and cancer diagnostics. Being knowledgeable about current trends will allow you to speak confidently about how you can contribute to the company's innovative goals.
✨Tip Number 4
Prepare to discuss your experience with ISO standards, particularly ISO13485 and ISO15189. Highlighting specific examples of how you've ensured compliance in past roles will set you apart as a strong candidate.
We think you need these skills to ace Head of Regulatory Affairs
Some tips for your application 🫡
Understand the Company: Research the biotech company and its innovative liquid biopsy technology. Familiarize yourself with their products, mission, and recent developments in cancer diagnostics to tailor your application.
Highlight Relevant Experience: Emphasize your experience in IVD medical device product development and your knowledge of regulatory standards such as ISO14971. Be specific about your previous roles and achievements that align with the job requirements.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your passion for innovation in cancer diagnostics and how your expertise can contribute to the company's goals. Make sure to address the key responsibilities mentioned in the job description.
Review and Submit: Before submitting your application, carefully review all documents for accuracy and completeness. Ensure that your CV and cover letter are well-formatted and free of errors, then apply through the provided link.
How to prepare for a job interview at Singular: Building Brilliant Biotechs
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the relevant regulatory frameworks, including MDR/IVDR and FDA regulations. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in the role.
✨Showcase Your Leadership Skills
As a Head of Regulatory Affairs, you'll be leading teams. Highlight your leadership experience and provide examples of how you've successfully managed teams in previous roles, particularly in high-stakes environments like medical device development.
✨Prepare for Technical Questions
Expect technical questions related to IVD medical device product development and ISO standards. Brush up on your knowledge of ISO13485 and ISO15189, and be ready to explain how you've applied these standards in your past work.
✨Demonstrate Your Passion for Innovation
This role is about pushing the boundaries of cancer diagnostics. Share your enthusiasm for innovation in this field and discuss any relevant projects or initiatives you've been involved in that showcase your commitment to advancing medical technology.
