Regulatory Affairs Associate - Medical Device Software part time fmx

We are Una a missiondriven company tackling the everincreasing burden of metabolic disease.

We are combining the latest medical research data science biosensor technology and humancentered design to enable sustainable behaviour change and improve health outcomes.

We have created the first medicalgrade digital therapy that sustainably solves metabolic dysfunction. Clinical studies have shown that our first digital therapeutic Una fr Diabetes improves blood sugars aids weight loss and improves users mental health.

We are backed by excellent investors such as Atlantic Food Labs PeakBridge Plug and Play and DART Labs and angels such as the founders of mySugr/9amHealth and Ada Health.

We are a fastgrowing team. You will be joining us at a hugely exciting time as we have just launched our fullyreimbursed solution to 9 million people living with type 2 diabetes in Germany.

As Regulatory Affairs Associate you will work directly with our Chief Medical Officer and PRRC Dr. Matthew Fenech and our Head of Engineering and Information Security Officer Yves Weissig. You will have the opportunity to contribute to the development and implementation of regulatory strategy in one of the most exciting areas of medical device regulation prescribed digital therapeutics. You will also be involved in our collaborations with colleagues at the Else Krner Fresenius Center for Digital Health at the Technical University of Dresden and at the Technical University of Munich with projects at the cutting edge of regulatory science focused on realworld evidence generation postmarket surveillance and improving informed consent processes for data sharing. We are committed to providing the successful candidate with opportunities for professional growth crossfunctional collaboration and active participation in shaping the future of metabolic disease management.

Note that this role is initially planned to be parttime (0.5 FTE) but there will be opportunities to increase this to fulltime for the right candidate.

Tasks

• Support Regulatory Strategy Development: Assist in the creation and execution of innovative regulatory strategies for digital therapeutics ensuring compliance while driving market access. Your regulatory intelligence gathering will provide critical insights that shape our product development and market strategies.
• Documentation and Submission Preparation: Collaborate with crossfunctional teams to prepare review and submit regulatory documentation to Competent Authorities Notified Bodies and other regulatory bodies.
• Maintaining and optimising Management Systems: besides ensuring that our Quality Management System and Information Security Management System adhere to the relevant standards and regulations (MDR GDPR ISO 13485 ISO 27001) you will identify opportunities to make our processes even more agile and robust and execute your ideas for improvement in collaboration with software engineers clinical experts and product experts.
• Compliance Audits and Inspections: Participate in internal and external audits and inspections gaining handson experience in compliance verification.

Besides these core tasks there will also be opportunities to be involved in:

• Training and Education Initiatives: Develop and deliver training sessions on regulatory requirements and updates for internal teams enhancing overall regulatory awareness and competency within the company.
• Stakeholder Engagement: Work with academic collaborators regulatory bodies industry groups and other stakeholders to contribute to the advancement of regulatory science and to advocate for our innovative digital therapeutics solutions.

Requirements

Research shows that there is a Confidence Gap between different groups (e.g. gender age ethnicity) leading some to apply when they meet 60% of the criteria and others only when they check every box. So if you think you have what it takes but dont necessarily meet every single point on the job description please still get in touch. Wed love to have a chat and see if you could be a great fit.

Qualifications: You have successfully completed a degree in natural sciences or engineering (e.g. process engineering nutritional science biology).

Experience: You have initial professional experience in the field of medical devices (regulatory or quality management) ideally specifically with medical device software.

Skills and knowledge: You are well organised and able to work independently in a solutionoriented manner and have a practical sense of what is actually doable. You are familiar with EU Medical Device Regulation ISO 13485 and ISO 27001. Familiarity with IEC 62304 and IEC 62366 requirements are a plus.

Attitude: You are motivated by our mission and the potential impact that digital health will have in our society and are excited by the prospect of exploring the role of novel technologies in the management of metabolic disease. You are communicative empathetic and friendly (creativity is a plus!). You are open to flexible working hours.

Language: You communicate confidently in English and have the ability to work in an international team. Fluency in written and spoken German is a plus.

Benefits

The opportunity to tackle one of the worlds leading health problems

A competitive package with salary and the potential for equity relevant to experience

Opportunities for hybrid/remote work

Unlimited holiday policy with a mandatory minimum

Budget for health and wellness apps

Healthy worklife balance and flexible working hours

An international team

A network of inspiring peers within our investor networks