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Clinical, Regulatory & Quality Manager

Daye

Daye

Legal, Quality Assurance
London, UK
Posted on Thursday, January 25, 2024

About Daye

At Daye, were on a mission to bridge the gender pain gap and become the leading destination in menstrual, vaginal and hormonal health. We have already established ourselves as a stand-out innovator in menstrual care offering the world's first CBD tampon for targeted pain relief, trusted by over 90,000 women. Now, were expanding our proposition to include two great services which put your own gynae health back in your own hands.

The first is a comprehensive diagnostic tampon which analyses the vaginal microbiome, identifying imbalances around vaginal infections, STIs and fertility.

The second is the world's first online Period Pain Clinic with science-backed pain management solutions and world class aftercare from our network of vetted, empathetic physicians who specialise in chronic pelvic pain. Our tool enables the faster diagnosis of chronic pelvic pain conditions, including endometriosis, adenomyosis, fibroids and other, meaning anyone who experiences pain can get answers, treatments and get their life back on track. We encourage women & AFAB folks to talk about their experiences and help find solutions rather than excuses - we know it's not just period pains.

Daye is now entering an exciting period of growth and expansion, with a focus on scaling our digital acquisition channels and helping Daye scale spend effectively on performance channels.

About the Opportunity

Daye is looking for a Clinical, Regulatory and Quality Manager to join the Product Team, based in Sofia, Bulgaria.

As a Clinical, Regulatory and Quality Manager, you will have the exciting opportunity to cover the domains of:

  • Continued ISO13485, GMP, and CQC compliance for our medical device and diagnostic products.
  • Continued HIPPA and ISO27001 compliance for our digital services.
  • Continuous quality improvement efforts across all business departments.
  • Risk management for both processes and products.
  • Production and supply chain digitisation in compliance with ISO13485, ISO27001, HIPPA, GMP and CQC.
  • Liaising with notified bodies and representing the company at external audits.
  • Continuous monitoring of changes in regulatory requirements or standards.
  • Research and clinical trial planning and management for current products to support regulatory submissions, including the Cannabidiol and the Diagnostic Tampon.
  • Continuous research and clinician engagement, including managing the Clinical Advisory Boards.
  • Grant funding applications and ongoing management.

What you'll be doing?

  • Overseeing Daye's clinical strategy, from planning trials to identifying research partners and securing grant funding opportunities.
  • Managing regulatory submissions for medical products, acting as a Regulatory Advisor on complex clinical trial projects.
  • Preparing and reviewing essential study documents and overseeing internal clinical and research activities.
  • Leading post-market surveillance for robust data collection and analysis to inform product development.
  • Identifying and submitting project proposals for grant funding and supporting various company departments.
  • Conference attendance, networking, and ensuring clinical research publications in prestigious journals.
  • Conducting OBGYN outreach and engagement.
  • Performing administrative tasks, including NCR, CAPA, and supplier evaluation forms.
  • Supporting various company departments on projects related to product development, commercialisation, and quality assurance.
  • Strategising continuous improvement for the Quality Management System (QMS) and leading internal audits.
  • Managing compliance with ISO13485 and GMP, liaising with suppliers, and introducing new joiners to QMS.
  • Directly managing a small team of 1 - 2 people and representing Daye in investor meetings and press interactions.

What you need to bring to the role?

  • Hands-on experience in startup and scale-up operations.
  • Experience with international standards such as ISO9001, ISO13485, ISO27001, and/or GMP.
  • Confident manipulator and presenter of data, combining strong analytical thinking with storytelling ability that generates buy-in for your recommendations.
  • Excellent communication skills and ability to interact with various external stakeholders.
  • Strong project management skills, including great comfort with managing budgets and timelines.
  • Comfortable with Microsoft Excel
  • Experience with Asana is a plus.

This position is for you if you are:

  • Passionate about female health.
  • Results driven.
  • Highly adaptable and comfortable with high levels of ambiguity.
  • Curious to ideate, test and measure new tactics.
  • You exhibit high levels of autonomy.

Why join us?

Working at Daye, you will be collaborating with a passionate, motivated and international group of top performers. Our team is big enough so you can grow, but lean enough so you can make a real impact. We're always pushing boundaries, for us thats the first step to a fulfilling and rewarding career. We move fast and we are not afraid of making mistakes or adapting. We believe no problem is too big to solve. We also believe everyone is an owner, which gives all of us at Daye the scope and space to grow. For this we offer:

  • Remuneration - Competitive pay rates with yearly salary reviews.
  • Growth - Paid training opportunities (e.g. certificates, conference visits).
  • Hybrid and Flexibility - Work whenever and wherever works best for you, Flexi Fridays.
  • Work-life balance - 20 days paid vacation per year excluding bank holidays and collective weeks off in August and between Christmas and New Year.
  • Parental Leave - Generous shared parental leave and return to work policy.
  • Healthcare - Private health insurance.
  • Wellness - Free coaching, Mental Health Days.
  • Work environment - Diverse, yet like-minded, casual & sociable community.

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

Only shortlisted candidates will be contacted.