Vacant job

Do you want to ensure quality within Life Science alongside some of the sharpest minds in the industry? Then this is where you belong. Here, you will find assignments that require curiosity, a solution-driven mindset, and sharp competence, giving you the chance to develop in new contexts. Together, we contribute to a better tomorrow and shape future solutions that make a difference for people and society.

Your Role

As a QA/RA (Quality Assurance and Regulatory Affairs) consultant with us, you will become a key figure for our clients. You will support them throughout the entire product lifecycle – from developing quality management systems to creating technical documentation. You will have ample opportunity to influence your own development and the chance to lead or participate in projects that make a real difference.

Key responsibilities include:

• Designing regulatory strategies and guiding clients through complex regulations (EU MDR/IVDR, FDA, MDSAP, etc.).
• Working on regulatory applications, submissions, and interacting with authorities and notified bodies.
• Ensuring efficient processes and procedures.
• Ensuring correct and complete technical documentation.
• Contributing to clinical and performance evaluations and implementing applicable standards.
• Being an active part of development projects where regulatory requirements must be integrated early.
• Sharing knowledge and building competence together with our experienced RA team.

How You Will Excel

You have the ability to make complex regulatory requirements understandable and build trust through your communicative style. You are meticulous, solution-oriented, and thrive in a role where you switch between strategic thinking and practical execution.

To succeed in this role, you have:

• At least 3 years of experience in QA/RA within medical technology or IVD.
• A university degree in Life Science (e.g., Civil Engineer, BMA, or PhD).
• Experience writing and updating technical documentation according to MDR/IVDR, as well as clinical/performance evaluations.
• Experience writing and adapting processes according to MDR/IVDR and ISO 13485.
• Excellent language skills in Swedish and English.
• Documented experience in one or more of the following areas: EU MDR/IVDR and associated guidelines, FDA applications (510(k), De Novo, PMA) and other regulatory pathways, MDSAP and international regulatory requirements, and standards for risk management, safety, and performance (ISO 14971, IEC 60601, IEC 62366, ISO 15189).

Being Part of Team PV

We are a consultancy firm passionate about Life Science, ranging from MedTech startups to global pharmaceutical companies. With us, you can follow the entire chain, from manufacturing to care, and work with regulations, audits, project management, and evaluations. What drives us is helping clients reach their goals and make a real difference for patients and society.

With us, you get something different. We distinguish ourselves from traditional consultancies through our unique culture, which stands out and permeates everything we do. We are extremely proud to be a Great Place To Work, year after year. Some say culture is in the walls. If ours were, we would have soft walls. Welcome to us at Plantvision!

Application

During the summer holiday period, it may take a little longer before you hear from us. We will begin the selection and interview process as soon as we are back from leave.

If you have questions about this position, please contact Pascal Skoglund at 072 566 99 87 or [email protected].

Do you have your own company and are interested in collaborating with us as a subconsultant?

Instead of applying for a specific position, please connect with us via our career page and state that you are interested in working as a subconsultant – we will get in touch when a suitable opportunity arises.