Clinical and Regulatory Specialist

About Daye

At Daye, were on a mission to bridge the gender health gap and become the go-to platform for menstrual, vaginal, and hormonal health.

We began by reinventing period care developing the worlds only medical-grade tampon. Daye is the only company that sterilizes tampons for safety, and we manufacture them according to medical device standards to ensure the highest possible quality. Our products are trusted by over 100,000 women and AFAB individuals across the UK and beyond.

Since then, we've expanded into diagnostic services with two unique at-home tools:

• Diagnostic Tampon for Vaginal Screening. A first-of-its-kind tampon that analyses the vaginal microbiome, screening for infections, STIs, and fertility-relevant markers. Together, our services help users connect the dots between their menstrual, vaginal, and hormonal health-empowering them with clarity, confidence, and control.

• The Period and Pelvic Pain Clinic, a first-of-its-kind digital health tool that helps users investigate the root causes of their period pain. Designed in collaboration with chronic pain experts, the clinic guides users through symptom tracking, diagnostic pathways, and personalised treatment recommendations. It supports earlier identification of conditions like endometriosis, fibroids, adenomyosis, and more while offering science-backed guidance and access to specialist clinicians.

• Hormonal Testing from Home. Our newest service, a simple, accessible testing service that gives users a detailed breakdown of their hormonal profile, with follow-up consultations to support their next steps.

Together, these services help people connect the dots between complex biological systems and take control of their health with clarity and confidence. Were now hiring a Clinical and Regulatory Specialist to join our growing team and support this next stage of our clinical care offering.

About the opportunity

Daye is a forward-thinking health technology company dedicated to advancing womens health through innovative medical devices and digital health solutions. We are seeking a highly motivated Clinical and Regulatory Specialist to join our dynamic team and support our mission to bring safe, effective, and user-centered products to market. 

What you'll be doing

• Usability & Lab Validation Support

  • Plan and conduct user research for usability studies, including participant recruitment, interviews, and data synthesis.

  • Support execution of CLIA/NY CLEP lab validations, including lab partner coordination, timeline oversight, and documentation.

  • Coordinate and maintain device labelling updates for STI & HPV under CLIA regulations.

• Regulatory Submissions Support

  • Draft 510(k) test reports and prepare submission-ready documentation.

  • Contribute to new product registrations and FDA presubmission activities.

  • Liaise with external regulatory consultants to gather and prepare regulatory submission materials.

• Quality Documentation & Compliance

  • Maintain and update Device History Files (DHFs) for all medical device products.

  • Coordinate with internal teams to draft post-market surveillance (PMS) reports.

  • Support risk assessments, technical file maintenance, and regulatory copy reviews.

  • Investigate complaints and clinical outcomes, ensuring proper reporting and vigilance requirements are met.

• Labelling & Regulatory Review

  • Coordinate labelling updates for new markets or regulatory changes.

  • Perform copy reviews for regulatory accuracy on product packaging and communications.

• Inspection & Audit Preparation

  • Prepare documentation and reports for external inspections (FDA, CE, CQC, MHRA).

  • Support Quality Management System (QMS) maintenance, including drafting CAPAs, NCRs, Work Instructions, and updating quality procedures.

  • Assist in gathering evidence and follow-up materials post-audit.

Required Qualifications

• Bachelors or advanced degree in life sciences, biomedical engineering, regulatory affairs, or a related field.

• Experience in medical device or digital health regulatory affairs, including familiarity with FDA, CE, and other global regulations.

• Experience with usability studies, lab validations, and clinical documentation.

• Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines.

• Excellent written and verbal communication skills.

• Collaborative mindset, with experience working cross-functionally and with external partners.

Youll Thrive Here If You Are

• Results-driven and highly adaptable.

• Comfortable with ambiguity and rapid change.

• Curious, proactive, and eager to test and measure new tactics.

• Autonomous, self-motivated, and entrepreneurial.

We Offer:

• Competitive remuneration.

• Equity Stock Options package.

• Growth - Paid training opportunities (e.g. certificates, conference visits).

• Hybrid and Flexibility - Work whenever and wherever works best for you.

• Work-life balance - 20 days paid vacation per year and 10 days of annual collective time off in August and December.

• Parental Leave - Generous shared parental leave and return to work policy.

• Wellness - Free coaching, Mental Health Days.

• Work environment - Diverse, yet like-minded, casual & sociable community.

Our Values

• Culture of Excellence: We never cut corners and always push boundaries.

• Customer First, Science Forward: Our decisions are data-driven and evidence-based.

• Everyones an Owner: We value accountability and proactive problem-solving.

• Ego Be Damned: We welcome feedback and adapt quickly.

• Long-Term Benefit: We prioritise whats right over whats easy.

• Different Paths, Same Destination: We unite around our shared vision.

Does this role sound like a good fit? Apply today by sending us your CV.

Only shortlisted candidates will be contacted.