QA/RA Medical Device Consultant

PharmaRelations

Sweden - Stockholm

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Are you passionate about Quality Assurance and Regulatory Compliance in the Medical Device Device companies? PharmaRelations is expanding its team of expert consultants, and we are looking for a talented QA/RA Medical Device Consultant to join us!

About the Role
As a QA/RA Consultant at PharmaRelations, you will work in a newly established team, delivering top-notch quality and regulatory services to our clients. You will work across the Medical Device sector, supporting a variety of tasks related to quality management and regulatory compliance. Your contributions will be essential in ensuring compliance with ISO 13485, ISO 14971, and EU MDR/IVDR regulations, as well as driving post-market surveillance and regulatory strategies.

This role offers you the flexibility to work with both startups and global organizations, providing a unique opportunity to grow while having a significant impact on client success.

Key Responsibilities:
In this role, you will be responsible for a variety of tasks aimed at ensuring regulatory compliance and high-quality standards for our clients. You will develop, implement, and maintain quality management systems (QMS) in line with ISO 13485 and other relevant standards. You will also be preparing and coordinating the technical documentation required for EU MDR/IVDRcompliance.

Key tasks include:

• Guiding clients through EU MDR/IVDR compliance, offering strategic advice on regulatory requirements.
• Compiling technical documentation and GSPR checklist, being part of a team to develop all parts of the technical documentation.
• Conducting internal and supplier audits to assess and improve their quality management systems.
• Acting as the QA/RA representative in project teams, providing expert insights to influence product development and compliance strategies.
• Leading post-market surveillance activities, managing vigilance reporting, and handling CAPA (Corrective and Preventive Actions) processes.
• In some cases, you may serve as the PRRC, ensuring all regulatory requirements are met.

Qualifications:
To succeed in this role, you’ll need a strong background in quality assurance and regulatory affairs within the medical device industry. We’re looking for someone with at least 3 years of experience in quality and/or regulatory roles.

Key qualifications include:

• A University degree in life sciences, engineering, or a related field.
• Extensive experience with ISO 13485, ISO 14971, and the MDR/IVDR regulatory framework.
• Strong communication skills in Swedish and English, both verbal and written.
• The ability to thrive in a collaborative team environment while also working independently when needed.
• Additional experience with global regulations outside the EU is a plus.

Why PharmaRelations?

At PharmaRelations, we offer more than just a job—we offer a strategic role where you can make a true impact within a small, highly skilled team. You’ll have the opportunity to work in a close-knit environment where your voice is heard, and your expertise is valued. With the freedom to take on diverse, meaningful projects, you’ll be a key player in supporting our clients' success while building your own career.

Joining PharmaRelations means becoming part of a forward-thinking community passionate about making a difference in patients' lives. We foster innovation, creativity, and personalgrowth, providing a supportive environment where you can excel, be valued, and truly make a difference.

We are committed to becoming the best workplace in the Nordic Life Science industry. Our ambition is to achieve the highest results among all Nordic Life Science companies in the Great Place to Work model. It’s a challenging goal, but one that pushes us to continuously improve and become a better employer year after year.

What We Offer:

At PharmaRelations, we believe in creating an inspiring and supportive work environment that promotes both personal and professional growth. As a QA/RA Consultant, you will:

• Work on exciting and varied projects across different medical device companies.
• Have the opportunity for continuous learning and career development.
• Enjoy a flexible and supportive work environment with a focus on work-life balance.
• Be part of a small team where collaboration, support, and teamwork are key.

Apply Now!
If you're excited about working in the medical device industry and making a real impact on product safety and compliance, we’d love to hear from you. Due to GDPR we cannot accept applications via email, please apply via our website.

If you have any questions please contact Emma Axelsson, Head of Medical Device (QA/RA), [email protected] or Helena Marteus, [email protected].

About PharmaRelations
PharmaRelations is a leading Nordic consultancy specializing in Life Science. We work with the top companies in the pharmaceutical, medical device, and biotech industries.

Join us and be part of a dynamic team committed to excellence in the Life Science sector!