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Medical Compliance and Quality Assurance Associate

Daye

Daye

Legal, Quality Assurance
Sofia, Bulgaria
Posted on Wednesday, February 14, 2024

About Daye

At Daye, we аre 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, we аre 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

To help deliver our products to women in the UK, Europe and the US, we're looking for an experienced and hugely talented individual to oversee and implement our medical compliance and quality assurance strategy for market approval.

You will be working closely with our internal research, product development and operations teams as well as external scientific and compliance consultants and advisors to bring our vision to life and youll be involved in every stage of the process; from exploring our initial ideas to helping deliver our full product in the hands of patients.

We are seeking talented and multi-skilled individuals who are passionate about women health and thrive in a fast-paced and energetic start-up environment. Being agile, open-minded and adaptable are key characteristics for success at Daye. The location of the position can be either Sofia, Bulgaria or UK.

What you'll be doing?

  • Commissioning, overseeing and delivering R&D, preclinical testing and clinical trials for Daye's women health products and services for the EU, UK and US markets;Maintaining the company's Quality Management System and ensuring that Dayes products are produced in compliance with the relevant standards and regulations for medical devices and software.
  • Collaborating with external advisors and regulatory consultants to ensure Daye's products are produced to validated and effective, and accessible to as many patients as possible.
  • Obsessing over scientific rigour & safety although Daye seeks to disrupt women healthcare by providing novel products direct to consumers, we hold ourselves to the highest standards internally and are seeking individuals that will continue to uphold and drive these standards.

What you need to bring to the role?

  • Eagerness to learn is a priority.
  • Experience and/or understanding of the medicinal product development process, including design and validation of medical devices and device-drug combination products.
  • Bachelors degree in a STEM field, including engineering, natural sciences, biomedical sciences.
  • 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.
  • Good organisational skills and the ability to understand various processes for product development.
  • Comfortable with taking responsibility and initiative, independent thinking and problem-solving skills.
  • Ability to work in a dynamic, fast-paced environment.
  • Proficiency in English (C1 or higher).

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.