About Occuity

At Occuity, we are pioneering ground-breaking technological solutions to alleviate some of humanity’s greatest healthcare challenges by developing technology that takes instant health diagnostic information simply by looking in the eye. With our clear vision and values, a world-leading team of experts, 9 international patents and more pending, we are developing a hugely innovative range of products that will improve the lives of millions of people around the world. Healthcare challenges are there to be solved and at Occuity, we have the vision and the technical ability to succeed. Occuity’s aim is for our accessible, non-contact, mobile diagnostic health devices to make repetitive, invasive monitoring a thing of the past.

At Occuity, we value being at the forefront of cutting-edge technology and we have an incredible team of people helping us do just that. Our employees are excited to be part of a team that thrives in a culture of innovation and imagination. Our success means that we are now expanding at a rapid pace and we are seeking truly exceptional people to join our team. We are looking for trailblazers, visionaries and the naturally inquisitive; those who can challenge and those who can inspire. At Occuity, every single person has a voice - and a vital contribution to make to our success.

If this sounds like you, why not join us on our journey?

The Role

Occuity is now seeking an experienced QARA individual to support the development of our new generation of portable, hand-held diagnostic medical devices.

With an ambitious vision to improve the lives of millions of people around the word, Occuity has the potential to deliver true innovation. You will play an important role in our future success. The QARA role will be fast-paced and exciting.

Key Duties & Responsibilities

• To oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause – with appropriate procedures developed and fully implemented
• Ensuring a sustainable, compliant quality management system that fully supports the current and future commercial needs of the business
• Ensuring that Design Quality controls are undertaken successfully for all projects. This will include Validation & Verification activities in order to meet the regulatory requirements on MDR2017/745/ FDA510k for launch in key markets, such as the EU/US
• Ensuring complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS
  
• Ensuring effective data management systems, policies, processes and programmes to provide assurances of ongoing statutory and regulatory compliance and delivery within budgets, whilst providing for a high level of internal and external customer satisfaction
• Remaining up to date with impending changes and developments regarding regulatory and compliance requirements, as well as evolving best practices in compliance control
• Developing, managing and maintaining the Occuity’s device family technical files and product specific design dossiers, ensuring compliance with the relevant regulations such as ISO14791, 60825 and 60601
• Developing and maintaining an excellent understanding of Occuity’s procedures and products
• Keeping up to date with changes in regulatory legislation and guidelines together with customer practices and changes to device standards and testing (globally)
• Providing sound advice to management throughout the development of new product and product enhancement submissions; this to ensure the principles of the submission accurately reflect the regulatory requirements to aid timely product introductions and certificate renewal processes
• Liaise with the company’s notified body/competent authority and overseeing the international submission processes
• Collaborating with Regulatory Affairs personnel from distributors and partners, providing assistance for the maintenance of international product registrations
• Ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organisation

Experience, Skills & Qualifications

Essential

• Degree educated, or equivalent, in a Life Science or Engineering discipline
• At least five years’ experience in medical device regulatory environment. MDR2017/745, ISO13485:2016 and FDA 510k
• An in-depth knowledge and appreciation of the regulatory requirements for placing medical devices on the European market Experience of North America, South America, Asia-Pacific markets would be highly desirable
• Strong leadership and influencing skills
• Experience building a high performing team, managing the performance of team members with varying levels of skill and experience, and providing support and mentorship
• Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales 
• Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required

Desirable 

• MSc or higher degree would be desirable for this role

Personal Attributes

• Enthusiastic and passionate
• Self-motivated, persistent and collaborative, you have a “can-do” attitude and approach
• A keen eye for detail
• Tenacious and persistent with a determination to go the extra mile to see all projects through to completion
• Equally capable of working independently or as part of a team
• An excellent communicator, you are adept at information sharing and contributing towards an open, positive team atmosphere
• You are excited about the prospect of making a real difference to people’s health around the world

Equality & Diversity

Occuity is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best.

Further details on our Equality, Diversity and Inclusion policy can be found online.