Quality Assurance and Regulatory Affairs Associate - No longer taking applications

Quality Assurance and Regulatory Affairs Associate - Software as a Medical Device

Salary £30,000-£40,000 PA

Remote

Full or part time considered

What’s in it for you? As Quality Assurance and Regulatory Affairs Associate at SiSU Health UK, your contribution to our growing team matters. You will thrive in a supportive environment driven by our purpose: helping everyone to live a healthier life and address health inequalities. 

You will enjoy working within an innovative culture focused on continuous learning. From day one you will play a pivotal role, witnessing the direct impact of your contributions. 

This opportunity will provide rapid development, where your proactive approach will make things happen, gaining invaluable experience across diverse up and coming projects.   

About you:  You are a pragmatic individual with 1- 2 years’ experience in regulatory affairs or quality assurance, enjoying roles that allow you autonomy and to really be part of something. You have a real attention to detail; you thrive in start-up environments where you leverage available resources to develop effective solutions. Your skill set includes excellent organizational abilities, adept analytical skills, managing priorities, and effectively communicating complex regulatory requirements. Your strong writing skills are evident in your capacity to compose and review extensive documents, while your communication skills enable you to convey information clearly and persuasively. 

Who we are:  SiSU Health UK (https://sisuhealth.co.uk) is a dynamic and innovative health tech business focused on preventative health. Our small Team is extremely driven and passionate about making a difference and work across Employer, NHS, Council and Pharmacy channels to bring our free health checks and pathways to everyone.    

Our proposition includes our SiSU Health Stations, on which more than 4.2 million self-service health checks have been completed worldwide and our SiSU app, with a health dashboard and lots of great features to support health improvement.   

Role overview

SiSU Health is moving through a period of strong growth, and due to this we are currently hiring a Quality Assurance and Regulatory Affairs Associate to join our team.

The day to day: 

·         Assist in preparing and submitting regulatory documentation ensuring adherence to relevant standards and regulations including ISO 13485.

·         Monitor and evaluate changes in regulatory requirements and ensure that the company's products and processes comply with applicable standards.

·         Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements.

·         Maintain organized and up-to-date regulatory files and documentation, supporting the efficient retrieval of information during audits or inspections.

·         Stay informed about changes in regulatory landscape and industry best practices, providing insights to support strategic decision-making.

·         Contribute to the development and maintenance of risk management documentation, ensuring alignment with regulatory expectations. Support initiatives relating to risk management and Information security (ISO 27001)

·         Assist in CE marking and EU MDR. 

Key requirements   

·         Bachelor's degree in a relevant field (e.g., Regulatory Affairs, Life Sciences, Engineering)

·         1-2 years of work experience in regulatory affairs or quality assurance within the medical device industry.

·         Familiarity with software-related regulatory requirements is highly desirable. 

·         Knowledge of ISO 13485 and ISO 27001 standards.  

We foster a culture of innovation and continuous learning as a team.  Everyone’s thoughts and ideas are encouraged, creating a dynamic environment where we constantly evaluate and improve our process for future success.  So, joining us here at SiSU will be both busy, challenging at times but highly rewarding.  As part of our small, yet growing team, you’ll have the opportunity to make a significant impact. You will be able to scale your experience alongside the business, and while we are constantly developing out our product, creating new propositions, entering new countries; it will be fast moving at times and there will be plenty of opportunity to work on interesting projects.  

In return we offer

· Discretionary Company Bonus (based on Business and Personal Performance)

· 25 days holiday

· Flexible working

· Personal Development and Qualifications

· Team Away Days

To apply email [email protected] with your CV & covering letter. All applications can expect a reply within two weeks.