Senior Regulatory Manager // Biotech // Guildford

Are you ready to drive regulatory strategy and compliance for innovative cancer diagnostics?

Did you join the biotech industry to make a real difference in patients' lives? We’re working with a Guildford-based biotech company at the forefront of cancer diagnostics with their Parsortix® liquid biopsy technology to find a Senior Regulatory Manager to join their team.

Your Opportunity

As a Senior Regulatory Manager, you'll be pivotal in ensuring regulatory compliance and advancing our groundbreaking technology. You will collaborate with R&D, clinical, and commercial teams to support new product development and global regulatory submissions.

What You’ll Do

• Lead and Manage: Line manage the Regulatory Assistant and coordinate with internal teams.
• Strategic Input: Contribute to regulatory strategy and planning to achieve project goals.
• Study Management: Design and oversee analytical and clinical verification/validation studies.
• Regulatory Submissions: Liaise with regulatory authorities to create and submit device registration materials.
• Post-Market Surveillance: Manage surveillance activities to meet regulatory requirements.
• Compliance Review: Review product promotional materials and external content for compliance.
• Quality Support: Support the ISO13485 quality system and secure/maintain quality accreditations.

What They Offer

• Innovative Environment: Be part of a team working on revolutionary cancer diagnostics technology.
• Career Growth: Gain valuable experience in a cutting-edge biotech company, with opportunities for professional development and advancement.
• Collaborative Culture: Join a team that values innovation, collaboration, and shared excellence.

Are You the One?

Do you have experience in medical device product development and a thorough knowledge of global medical device regulations? Are you detail-oriented with a flexible, can-do approach?

Qualifications, Experience, Knowledge, and Attributes:

• Experience with ISO 14971 and medical device product development.
• Proven track record of developing regulatory pathways and obtaining global approvals.
• In-depth knowledge of global medical device directives, regulations, and standards.
• Highly detail-oriented and capable of managing multiple projects simultaneously.

Job Requirements:

This position is based in Guildford with flexibility for remote work. Travel to Guildford sites and third-party study sites may be required.

If you’re ready to make a difference in cancer diagnostics, apply now or reach out with your CV to nicole@singulartalent.io.

We look forward to hearing from you!