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Работа в България?
София, ул. „Граф Игнатиев“ № 11, ет.1, ап.3

Bulgaria Wants You


DAYE - Senior Clinical & Regulatory Manager

Описание на длъжността

About Daye

Daye is a highly ambitious R&D startup on a mission to raise the standards in the female healthcare industry. Our aim is to bridge the gender gap in medical research and product innovation by designing products rooted in scientific rigor and inspired by the female intuition.

We are building a comprehensive gynae health platform that will address all areas of female health, from the first menstruation up to menopause, and beyond.

We started by upgrading the tampon and after 3 years of R&D, in 2020 we launched the world’s first pain-relieving tampon. We quickly expanded our product portfolio to cover vaginal health with our ProViotics - the first microbiome safe treatment for recurrent infections. We are currently working on several new digital and physical products and are in the process of expanding to the US market.

Our team of 50, based in London and Sofia, is changing the face of gynae health for the better, and we need exceptional talent to help achieve our mission.

Изисквания за длъжността

About the opportunity

We are looking for a Senior Clinical & Regulatory Manager to join our team in London or Sofia or work remotely.  You will be an integral part of the Product team working closely with the CPO, Senior Product Manager and Clinical & Regulatory Associate. You will be responsible for  all of Daye’s regulatory approvals across different geographies (mostly Europe and the US), as well as looking after  all ongoing and future clinical studies.

The ideal candidate has a proven track record of successfully executing clinical and regulatory strategies for novel medical devices. They are passionate about  advancing medical research to find solutions to unmet female health needs. They are experienced in planning robust clinical trials and navigating complex regulatory challenges in the field of medical devices. They are highly organized, comfortable with ambiguity and thrive in dynamic environments.

Over the next 12 months, our aim is to grow our current subscriber base exponentially, which means you’ll be part of a company on an extremely high growth trajectory. This is a fantastic opportunity to make a real impact quickly by streamlining Daye’s regulatory strategy, opening up new geographies as potential market opportunities for Daye’s novel products.

If you enjoy complex regulatory challenges, want to be part of break-through clinical research, and to work in a dynamic, high growth start-up, we’d love to hear from you!

What you’ll be doing

  • Managing and executing Daye’s clinical strategy through:
    • Planning of pre-clinical and clinical trials to evaluate the safety and efficacy of new products;
    • Identifying and attracting relevant research partners from Academia and Clinical backgrounds to continuously collaborate with on Daye’s ongoing and future research;
    • Review existing and newly published literature, relevant to Daye’s work, current and new products to expand our scientific backing and knowledge and support product innovation;
    • Identify and secure grant funding opportunities for clinical research;
  • Managing regulatory submissions for Daye’s medical products, compiling technical documentation (CE Technical files, 510k submissions, etc), managing regulatory timelines and budgets, leading communication with Notifying Bodies and regulatory agencies.
  • Managing Daye’s post-market surveillance activities to support the collection of robust, reliable data. Create systems for capturing and analyzing data from various sources (customer complaints, feedback surveys, medical research, competitor analysis, etc.) to continuously inform and support product development and improvements.
  • Identifying grant funding opportunities and submit project proposals for the development and clinical validation of new and existing products

Assisting the CPO,

Senior Product Manager and Head of Operations

and other company departments as needed across projects relating to product development and commercialisation

What you need to bring

  • Background in regulatory affairs and compliance of medical devices and/or medical software in the EU and US. You will have experience working with engineering and business teams on taking medical products from concept to market and post-market improvements.
  • Experience communicating with regulatory agencies (MHRA, FDA or others) and solid understanding of regulations, including MDR and IVDR and Quality Management Systems (ISO13485)
  • Experience with clinical trial design and planning
  • Bonus: Clinical background and experience or good understanding of clinical terminology and female physiology.
  • Excellent self-organization skills and ability to deliver to tight deadlines while working across multiple projects.
  • An impeccable attention to detail and a deep commitment to accuracy.
  • Proven ability to adapt to changes easily and learn on the go.

Is Daye right for you?

You will thrive at Daye, if you like dynamic, fast-paced environments and you are comfortable with high levels of ambiguity. This is your place, if you like being proactive and hands-on while wearing many hats. We want to hear from you, if you see yourself in all of the above, and you share our core values:

  • Culture of excellence. Persistent AF. We take pride in our work, never cutting corners, always pushing boundaries and persisting in the pursuit of our goals.
  • Customer first. Science forward. Our decisions are driven by our consumers’ best interests and based on data, evidence and research.
  • Everyone’s an owner. We believe in accountability and proactively seeking answers and solutions.
  • Ego be damned. Feedback and constructive criticism are always welcome because we’re not afraid of speaking out, making mistakes or adapting.
  • Long-term benefit over short-term gain. We have the courage to do the right thing, even if it’s not the easiest thing to do at this very moment.
  • Different paths, same destination. Every conversation is approached with the understanding that we’re all on one team, because even though everyone may have a different perspective, we have a shared vision.

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 that’s 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)
  • Flexibility - Work whenever and wherever works best for you, Flexi Fridays
  • Work-life balance - 30 days paid vacation per year including bank holidays
  • Parental leave - Generous shared parental leave and return to work policy
  • Healthcare - Private health insurance
  • Wellness - Free professional coaching, Mental Health Day
  • Work environment - Diverse, yet like-minded, casual & sociable community

How to Apply

Does this role sound like a good fit? Tell us about you, your experience and why you are interested in this job.

  • Include the role's title in your subject line.
  • Attach your latest CV and send along links that best showcase the relevant things you've built and done.
  • Press send and we’ll get back to you within 1 week.

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