Senior Manager/Director of Regulatory Affairs

2 weeks ago

Guildford Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

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.

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.

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.
Regulatory Submissions: Liaise with regulatory authorities to create and submit device registration materials.
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.

Career Growth: Gain valuable experience in a cutting-edge biotech company, with opportunities for professional development and advancement.
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?

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.

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

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