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2018 Entia Ltd Copyright

Head of Regulation and Quality

Entia Ltd,  Highbury, London, UK

Full-Time, London UK

Entia is looking for a Head of Regulation and Quality to join the company’s management team. You will be responsible for all regulatory matters across Entia’s product portfolio and for ensuring the company’s quality processes meet and where possible exceed their requirements.

Entia is an award-winning medical device technology company. Entia’s purpose is to make life-changing health conditions easier to live with by enabling treatment and management to take place at home.

Entia is backed by some of the UK’s leading venture capital investors and is linked with many internationally recognised healthcare providers. We have unique, award-winning technology and are targeting major global healthcare markets.

 

What You'll Do:

  • Oversee the development of the company’s regulatory strategy for pre-market applications and related submissions.

  • Provide guidance to cross-functional product development teams regarding conformance with in vitro medical device regulations and standards.

  • Oversee international product registrations.

  • Support the Quality Manager in the continual enhancement of the quality management system.

  • Work alongside a multi-disciplinary team to maintain, develop and improve the company’s Quality Management System.

  • Work with the Quality Manager to assemble and submit technical files.

  • Ensure the company’s quality management system is maintained and remains compliant with ISO 13485 and FDA 21 CFR 820.

  • Continually assess the regulatory landscape and adapt the company’s quality management system and product registrations to any changes.

  • Assist with the development of procedures, forms and work instructions where needed.

  • Oversee training staff on procedures, forms and work instructions where needed.

You are:

  • Someone who has excellent communication skills and the ability to explain your work in a multi-disciplinary environment.

  • Proactive and capable of taking ownership for your work.

  • Capable of working independently and collaboratively.

You Must Have:

  • 8+ years experience in a relevant role.

  • Extensive experience with:

  • IVDD (and an understanding of IVDR).

  • ISO 13485:2016.

  • FDA 21 CFR 820.

  • cGMP.

  • Software development practice (IEC 62304:2006/Amd 1:2015).

  • Self-testing Non-Annex II IVDs.

  • Degree in the sciences, management or a related field.

  • Experience working in an SME.

  • Leadership skills.

  • Management experience and integrity.

  • Understanding of data privacy standards (GDPR)

 

Ideally, You Will Have:

  • Experience working with digitised quality management systems

  • Demonstrated implementation of quality management system software solutions

  • Ability to identify and execute opportunities for QMS automation of processes

 

What We Can Offer:

  • The opportunity to hold a management position within a rapidly growing company.

  • The chance to create your own systems and processes with far-reaching impact.

  • Regular team-building company events - monthly team lunches, international team trips and more.

  • A flexible and fun work environment filled with passionate and extremely capable people.

  • We encourage and support professional development, and internal career progression to see every Entia employee achieve their greatest potential.

  • A well-stocked fridge, biscuits and fruit as well as endless tea and coffee to keep us going throughout the day.

  • Collaborations with world-leading research institutions and companies.

  • The opportunity to work on a product that will improve the lives of millions of people.

 

Entia does not accept agency resumes or other unsolicited contact. Furthermore, Entia is not responsible for any fees related to unsolicited resumes.