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Clinical, Regulatory & Quality Manager

Daye

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Posted over 30 days ago...

Expired

Join the innovative Daye team as a Clinical, Regulatory and Quality Manager and become a leader in bridging the gender pain gap

Overview

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No salary declared 😔

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London, England, United Kingdom

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98% Remote- Europe

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Expires at anytime

Organisation summary: Daye is revolutionizing menstrual, vaginal, and hormonal health with a focus on reducing gender pain disparities. Already known for creating the first CBD tampon, Daye has gained the trust of over 90,000 women and is continuously expanding its health services. At Daye, innovation is at the forefront, and the team is committed to providing groundbreaking solutions that empower women's health.

Role Summary:

  • Maintaining compliance with ISO13485, GMP, and CQC for medical devices and diagnostics.
  • Ensuring HIPPA and ISO27001 compliance for digital services.
  • Driving quality improvement in all departments.
  • Implementing risk management for processes and products.
  • Advancing production and supply chain digitization in line with international standards.
  • Coordinating with notified bodies and managing external audits.
  • Monitoring regulatory changes and adapting accordingly.
  • Managing research, clinical trials, and Clinical Advisory Boards for product support.
  • Securing and overseeing grant funding.

Role Requirements:

  • Proven experience with startup and scale-up operations.
  • Familiarity with ISO9001, ISO13485, ISO27001, and GMP standards.
  • Adept at data analysis, presentation, and persuasive storytelling.
  • Excellent communication and stakeholder interaction skills.
  • Proficient in project management, budgeting, and timeline oversight.
  • Comfortable with Microsoft Excel; Asana experience is a bonus.

Benefits:

  • Competitive salary with annual reviews.
  • Paid training and personal development opportunities.
  • Hybrid work schedule and 'Flexi Fridays'.
  • 20 days paid vacation, plus additional company-wide breaks.
  • Generous parental leave policy.
  • Private health insurance and wellness support.
  • An impactful role in a diverse and dynamic team.

About Daye At Daye, we're 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're expanding our proposition to include two great services which put your own gynae health back in your own hands.

The Role Daye is looking for a Clinical, Regulatory and Quality Manager to join the Product Team in one of our offices in UK or 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.

Job Requirements 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.

Benefits 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.

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