Senior Quality & Regulatory Specialist

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.