Job Description

About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

We are now looking for Senior QA/RA Experts – MedTech Software (MDR / SaMD) to join an exciting and high-impact engagement in Stockholm.

In this role, you will support a large public healthcare organization in establishing, adapting, and implementing a quality management system (QMS) and technical documentation in line with NMI (HSLF-FS 2022:42), MDR 2017/745, and relevant standards such as ISO 13485 and IEC 62304. You will work both strategically and hands-on, ensuring regulatory compliance, quality assurance, and long-term sustainability of processes and systems.

As part of our SRS/FSP team, you will be dedicated to one client within a complex healthcare environment, working closely with cross-functional stakeholders including technical teams, product owners, and regulatory functions.

Key Responsibilities

• Contribute to the completion and implementation of an existing Quality Management System (QMS) aligned with ISO 13485, NMI, and MDR
• Perform gap analyses, classifications, and assessments of systems, services, and products against applicable regulatory frameworks
• Review, update, and develop technical documentation for medical device software (SaMD)
• Support the development and execution of a regulatory compliance roadmap, including processes, documentation, and governance structures
• Collaborate with stakeholders to define roles, responsibilities, and organizational setup for quality and regulatory functions (including PRRC considerations)
• Evaluate and define requirements for electronic QMS (eQMS) solutions
• Provide hands-on support within areas such as risk management, usability, labeling, clinical evaluation, and post-market surveillance
• Act as a subject matter expert, supporting interpretation and application of relevant regulations and standards

Qualifications

• Minimum 5 years of experience within QA/RA in the medical device or medtech software domain
• Strong hands-on experience with QMS implementation and technical documentation under MDR and/or NMI
• Experience working with ISO 13485 and IEC 62304 (SaMD)
• Proven ability to work both operationally and strategically within complex regulatory environments
• Experience collaborating with cross-functional teams in technical and business settings
• Fluency in Swedish and English, both written and spoken

Meritorious:
• Experience from public healthcare organizations or large, complex environments
• Experience supporting certification processes with notified bodies
• Experience with eQMS evaluation and implementation
• Experience working with both NMI and MDR frameworks

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the healthcare landscape.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.