English
SyntheticMR’s solutions deliver objective data that can help improve diagnosis, monitoring and treatment of patients.
SyntheticMR’s products are currently sold directly to customers through our regional sales offices in the USA, India, Japan, Germany, South Korea and China. The company has partnerships with GE Healthcare, Siemens Healthineers , Philips Healthcare, Fujifilm, United Imaging, Hyland Healthcare, and Canon Medical Systems.
Vision and mission
SyntheticMR’s vision is to empower clinicians with efficiency and confidence to improve patient outcomes.
SyntheticMR’s mission is to make quantitative imaging solutions the standard of care to support more precise diagnosis, reliable monitoring and personalized treatment strategies. Built on sustainability, innovation and trust, we strive to improve patient care worldwide.
SyntheticMR’s products are currently sold directly to customers through our regional sales offices in the USA, India, Japan, Germany, South Korea and China. The company has partnerships with GE Healthcare, Siemens Healthineers , Philips Healthcare, Fujifilm, United Imaging, Hyland Healthcare, and Canon Medical Systems.
Vision and mission
SyntheticMR’s vision is to empower clinicians with efficiency and confidence to improve patient outcomes.
SyntheticMR’s mission is to make quantitative imaging solutions the standard of care to support more precise diagnosis, reliable monitoring and personalized treatment strategies. Built on sustainability, innovation and trust, we strive to improve patient care worldwide.
Head of Quality Assurance & Regulatory Affairs
Combine Strategic Influence with Hands-On Impact in Innovative MedTech
Do you want to play a key role in shaping the future of innovative MRI software technology in healthcare?
SyntheticMR is now looking for a driven and collaborative Head of Quality Assurance & Regulatory Affairs to join the company’s continued growth journey. This is an exciting opportunity to combine strategic influence with hands-on operational work in an international and technology-driven MedTech environment.
The role is suitable both for:
Experienced QA/RA leaders, and
Senior specialists or leadership talents ready to take the next step into a broader leadership role.
About SyntheticMR
SyntheticMR develops innovative software solutions that enhance Magnetic Resonance Imaging (MRI) workflows and improve clinical decision-making. The company is a pioneer within quantitative MRI and provides advanced imaging solutions to healthcare providers and partners globally.
Headquartered in Linköping, Sweden, SyntheticMR combines scientific excellence, entrepreneurship and advanced software technology to improve patient care worldwide.
The Role
As Head of QA & RA, you will have a central role in ensuring quality, regulatory compliance and continuous development of SyntheticMR’s products and processes.
The role combines:
Strategic QA/RA leadership, and
Operational involvement in day-to-day quality and regulatory activities.
You will work cross-functionally with key stakeholders across the organization and contribute both strategically and operationally to SyntheticMR’s continued growth and product development.
Depending on your background and experience, the role can evolve over time regarding leadership responsibility and organizational scope.
Key Responsibilities
- Lead and further develop Quality Assurance & Regulatory Affairs activities
- Maintain and continuously improve the Quality Management System (QMS)
- Support and drive regulatory strategies and compliance activities globally
- Contribute to product development, software lifecycle processes and quality-related initiatives
- Support audits, inspections and external collaborations
- Drive continuous improvements and strengthen the quality culture within the organization
- Collaborate closely with R&D, Operations, Product Management and leadership team
We Are Looking For
We are looking for a person with a strong combination of:
quality mindset,
strategic thinking,
collaboration skills, and
drive.
You may currently work as:
Head of QA/RA,
QA/RA Manager,
Senior QA/RA Specialist,
Regulatory Affairs Specialist,
Quality Manager,
or in another relevant MedTech/Life Science QA/RA role.
Most important is your potential, motivation and ability to contribute in a growing and dynamic environment.
Experience & Qualifications
We see several of the following as relevant:
- Experience within QA and/or RA in a regulated industry
- Experience from MedTech, software, SaMD (Software as a Medical Device), Life Science or related areas
- Knowledge of relevant regulations and standards such as:
ISO 13485
MDR / IVDR
IEC 62304
- Experience working in cross-functional organizations
- Leadership experience is beneficial, but leadership potential and ability to influence are equally valuable
- University degree in engineering, science, medicine or similar
- Fluent professional English
Personal Profile
We believe you are:
- Strategic and analytical
- Structured and quality-oriented
- Collaborative and communicative
- Curious and solution-oriented
- Comfortable balancing strategic and operational work
- Able to build trust and create engagement across the organization
Why SyntheticMR?
This is an opportunity to:
- Join an innovative and international MedTech company
- Work with advanced MRI software technology that contributes to improved healthcare
- Have a meaningful impact on products, processes and ways of working
- Combine strategic influence with operational involvement
- Be part of a collaborative and entrepreneurial culture
- Grow professionally together with the company
Location
The position is based at SyntheticMR headquarters in Linköping, Sweden, with flexibility for hybrid work.
Application and dialogue
For more information and a dialogue about the position, please contact:
Magnus Klingberg
Senior Recruitment Consultant / CEO
PeakSearch
magnus.klingberg@peaksearch.se
+46 (0)70-678 09 92
We look forward to hearing from you!