Job Openings

Quality & Regulatory Compliance Officer



What you will do

We are looking for a talented Quality & Regulatory Compliance Officer to take over the management of the processes across the company, ensuring compliance is maintained. This includes monitoring activities in product development, manufacturing and commercialisation of our medical devices.

This will include:

  • Quality Management:
    • Responsible for the company ISO 13485 compliant Quality Management System, defining and improving SOPs and maintaining all QMS Records up to date.
    • Ensure products are developed, manufactured, imported and distributed according to required regulations and standards of each country, including risk management.
    • Plan and conduct internal audits to ensure compliance across functions, and coordinate external surveillance audits from Notified Bodies and Competent Authorities.
    • Prepare the requirement documentation to obtain certifications and commercialisation authorisations.
  • Compliance/Regulatory:
    • Define and track changes to the regulatory needs in each region/country, define and execute action plans to remain compliant, produce the documentation required and manage submissions to the different national Competent Authorities in Europe.
    • Build suitable relationships and act as primary contact with regulatory agencies (ie: Competent Authorities, Notified Bodies, etc).

What you should bring to Acurable

  • Experience in the healthcare industry with minimum 2 years in a medical devices regulatory environment.
  • Proven track-record in ensuring compliance with MDD/MDR requirements, experience with FDA requirements is a plus (but not essential).
  • Knowledge of the national medical devices regulatory guidelines and legislation in European markets, including reporting to Competent Authorities.
  • In-depth understanding of ISO 13485 requirements and practical experience maintaining QMS processes and records.

Why you should apply

  • We provide a fun and entrepreneurial work environment within an exciting high-growth business, where you will use your skills to make a real difference to the lives of millions of people.
  • You will be joining an experienced and extremely talented team, who will help you grow professionally by providing valuable mentoring and development opportunities.
  • We offer a very competitive remuneration package, flexible hours, generous holiday allowance, regular social events… and many other perks we continue adding as the company grows.
  • We put time and care into finding passionate, committed people, who look out for each other and are prepared to go the extra mile to help Acurable achieve our mission. If that sounds like something you’d like to be a part of, we can’t wait to hear from you.

Position details

  • Location: Post-Covid, you’ll be based at the company headquarters in London, but still with the option to work remotely as and when required.
  • Team: You will work with team members across all departments.
  • Compensation: Competitive salary based on skills.

HOW TO APPLY

Please send your CV to careers@acurable.com with the subject “Application - Quality & Regulatory Compliance Officer position”, including an introduction about why you want to join our company, why you think you are the right candidate for the position, your salary expectations and current location. You can view our recruitment privacy policy here.

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About Acurable

Acurable is a fast-growing, venture backed MedTech start-up with offices in London and Seville. We create accurate and user-friendly wearable medical devices intended to be used by patients at home.

Our award-winning, patented technology enables for the first time the automated diagnosis and management of respiratory conditions. It is the product of more than 10 years’ research at Imperial College London by Acurable’s founder, Professor Esther Rodriguez Villegas, and has been recognised as a breakthrough in respiratory medicine, winning some of the most respected awards in the industry, among them XPrize and several Innovate UK grants.

Our first product, AcuPebble SA100, is the first medical device in the world to obtain the CE mark for the automated diagnosis of obstructive sleep apnoea at home. Meanwhile we continue our research to develop new products that will fundamentally improve the lives of millions of people suffering from serious chronic conditions such as COPD, Asthma and Epilepsy.

We’re a small but fast-growing team with big ambitions. To achieve them, we’re building a team of exceptional people who are inspired by our vision, share our values, and who have the attitude and skills required to help Acurable succeed. In return, we provide a fun and entrepreneurial working environment within an exciting business where you can make a huge difference to the life of millions of people worldwide.


More about Acurable