QARA Manager

Cure Talent is delighted to be exclusively partnered with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their goal is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance outcomes and save lives.

This is a hybrid role offering flexible home and site working arrangements.

As they embark on this journey, we have an exciting opportunity for a RAQA Manager to play a pivotal role in achieving regulatory approvals for their innovative medical devices. In this brand-new role, you will lead efforts to secure UKCA Marking, CE Marking, and FDA approvals while supporting compliance with MDR and IVDR. Collaborating closely with internal teams, you will ensure smooth regulatory pathways for new product approvals and contribute to post-market regulatory activities.

To be successful in this role, we are looking for an experienced Regulatory Affairs professional with a strong track record of navigating UKCA, CE, and FDA regulatory frameworks. You will thrive in a smaller, fast-paced organisation and bring a proactive, solution-oriented approach to the early-stage product development process. Knowledge of IVD regulations and prior experience in securing regulatory approvals for innovative products are highly desirable.

Responsibilities:

• Lead regulatory strategies for achieving UKCA Marking, CE Marking, FDA approvals, and compliance with EUMDR and IVDR.
• Manage and oversee regulatory submissions for new product approvals.
• Develop and maintain regulatory documentation to support product compliance and market entry.
• Collaborate with internal teams to ensure regulatory requirements are met throughout the product lifecycle.
• Support post-market regulatory activities, including vigilance and adverse event reporting.
• Provide guidance on regulatory changes and ensure ongoing compliance with applicable standards.

Qualifications:

• Proven experience in a senior Regulatory Affairs or QARA role within Medical Devices.
• In-depth knowledge of UKCA Marking, CE Marking, FDA regulatory pathways, and EUMDR/IVDR requirements.
• Strong understanding of regulatory submission processes for new product approvals.
• Experience working with IVDs and associated regulations is highly advantageous.
• Excellent organisational and communication skills, with the ability to manage complex regulatory projects in a fast-paced environment.

If you are a driven and innovative professional ready to make a significant impact in a growing company, we would love to hear from you. Get in touch with Kris Holmes at Cure Talent today!