Arbetsbeskrivning

Do you believe in the power of processes and efficiency? We’re looking for a key player to support our compliance with medical device requirements and standards. In this role, you’ll have the freedom to shape and drive regulatory and quality processes, take ownership of compliance initiatives, and work closely with cross-functional teams in Sweden, the UK and Norway, including product development.

What you can expect in the role This role will be part of our Regulatory Team, a cross-functional team including roles such as Legal Counsel, QA Tester, and Product Manager, among others.

Given that we work in a fast-paced and dynamic environment, with a small and agile team, this role may go beyond a traditional regulatory/compliance position. You won’t just follow processes – you’ll help define and improve them. But don’t worry, you won’t be starting from scratch. We have an ISO 27001 and ISO 13485 compliant management system in place.

The placement is either at Visiba’s headquarters in Gothenburg/Mölndal, or at our office in Örebro with flexible working hours and a hybrid workplace.

Key responsibilities may include:

• Developing, implementing and improving processes in line with ISO 13485, ISO 14971, and IEC 62304, along with other relevant standards.

• Developing and maintaining technical documentation for SaMD according to the MDR.

• Supporting a broad spectrum of quality and regulatory activities, such as post-market surveillance, non-conformity management, internal audits, and risk management.

• Coordinating and leading audits conducted by our notified body.

• Supporting regulatory submissions and liaising with notified bodies and authorities.

• Providing internal training and guidance on regulatory and quality requirements.

We don’t expect you to be an expert in everything, but you should know your way around SaMD standards and requirements and feel confident tackling new topics, approaching challenges with a creative mindset, and seeking guidance when needed.

Who you are To thrive in this role, you need to be self-propelled with an interest in bringing value towards customers and end-users. You do not hesitate to think outside the box, and you focus on solutions instead of problems. You believe that the best results come from collaboration, and it is easy for you to reach out and communicate with others to create understanding of your point of view.

Required Experience/Qualifications

• Good knowledge of MDR (EU 2017/745) and its application to SaMD, including supporting standards such as ISO 13485, ISO 14971, and IEC 62304.
• Experience implementing and improving quality management systems for SaMD.

• Experience developing and maintaining MDR technical documentation for SaMD.

Required Skills/Interests - you need to recognise yourself in below

• Professional proficiency in English, both written and spoken. Swedish is a plus.

• Strong communication and project management skills. You’re great at breaking down regulatory requirements so others can easily understand them.

• You take initiative and drive work forward independently, seeking help from the team when needed but not waiting for others to tell you what to do.

• You believe in keeping policies and processes clear and straightforward, without overcomplicating things.

Experience from one or several of the below is an added bonus

• Experience working in a startup or fast-paced MedTech environment.

• Experience working as a Person Responsible for Regulatory Compliance (PRRC) under the MDR, or possessing the qualifications and professional experience required to be designated as PRRC for SaMD.

• Experience working with ISO 27001 and cybersecurity requirements for SaMD.

If you’re excited about the freedom to shape and drive regulatory work in a small but experienced MedTech company at the forefront of the rapidly evolving AI triage market, this role is for you!

What we offer We offer the possibility to be part of a journey to change the world by improving healthcare with new and innovative products. We believe that we achieve great things by supporting and challenging each other, and not least by having fun together! We offer:

• A challenging environment where we guarantee that you will grow and be challenged

• Time for exercise during working hours, as we believe in the importance of physical exercise to increase well-being and performance

• Wellness allowance

• Medical insurance

• 30 days paid leave

• ... and a lot more

Please send in your application in English or Swedish.

Selection takes place continuously, so do not hesitate to send in your application as soon as possible. If you have any further questions regarding the recruitment or the position please contact: Sandra, Head of People & Culture at [email protected]

About Visiba Visiba has provided smart technology to help healthcare providers deliver better care since 2014. Today we stand at the forefront of powerful AI-enabled triage. Founded as a purpose-driven company in 2014, Visiba's mission is to empower healthcare providers and improve people's lives.

Currently, we have one medical device, Red Robin, an AI-powered SaMD intended to automate pre-clinical triage and initial medical history-taking, to support clinical decision-making and patient management.

If you want to learn more about who we are and what we do, visit www.visibagroup.com