Do you want to help ensure quality in Life Science together with the industry's sharpest minds? Then this is where you belong. With us await assignments that require curiosity, drive for solutions, and sharp expertise—and that give you the chance to develop in new contexts. Together we contribute to a better tomorrow and shape the solutions of the future that make a difference for people and society.
This will be your role
As a QA/RA (Quality Assurance and Regulatory Affairs) consultant with us, you will become a key person for our customers. You will support them throughout the entire product lifecycle—from developing quality management systems to creating technical documentation. You will have great scope to influence your own development and the opportunity to lead or participate in projects that make a real difference.
The role includes, among other things:
- Designing regulatory strategies and guiding customers through complex regulations (EU MDR/IVDR, FDA, MDSAP, etc.).
- Working with regulatory submissions, applications, and interactions 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 expertise together with our experienced RA team.
Here's how you will excel
You have the ability to make complex regulatory requirements understandable and create trust through your communicative style. You are thorough, solution-oriented, and thrive in a role where you switch between strategic thinking and practical execution.
To succeed in the role you have:
- At least 3 years of experience in QA/RA within medical devices or IVD.
- A degree from a university or college in Life Science (e.g., MSc in Engineering, BMA, or PhD).
- Experience writing and updating technical documentation according to MDR/IVDR as well as clinical/performance evaluation.
- Experience writing and adapting processes according to MDR/IVDR and ISO 13485.
- Very good language skills in Swedish and English.
- Documented experience in one or more of the following areas:
- EU MDR/IVDR and associated guidelines.
- FDA submissions (510(k), De Novo, PMA) and other regulatory pathways.
- MDSAP and international regulatory requirements.
- Standards for risk management, safety, and performance (ISO 14971, IEC 60601, IEC 62366, ISO 15189).
Being part of Team PV
We are a consulting firm passionate about Life Science, from MedTech startups to global pharmaceutical companies. With us you get to follow the entire chain, from manufacturing to healthcare, and work with regulations, audits, project management, and evaluations. What drives us is helping customers achieve their goals and making a real difference for patients and society.
With us you get something different. We distinguish ourselves from traditional consulting firms through our unique culture, which stands out and permeates everything we do—and we are extremely proud to be a Great Place to Work, year after year. Some say culture lives in the walls. If ours had, we'd have soft walls. Welcome to us at Plantvision!
Application
During the holiday period it may take a bit longer before you hear from us. We will begin the selection and interview process as soon as we return from vacation.
If you have questions about this position, feel free to 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 subcontractor?
Instead of applying for a specific position, please connect with us via our careers page and indicate that you are interested in working as a subcontractor—we'll get in touch when something suitable comes up.Do you want to help ensure quality in Life Science together with the industry's sharpest minds? Then this is where you belong. With us await assignments that require curiosity, drive for solutions, and sharp expertise—and that give you the chance to develop in new contexts. Together we contribute to a better tomorrow and shape the solutions of the future that make a difference for people and society.
This will be your role
As a QA/RA (Quality Assurance and Regulatory Affairs) consultant with us, you will become a key person for our customers. You will support them throughout the entire…