Vacant job

Do you want to help ensure quality in Life Science alongside the sharpest minds in the industry? Then this is where you should be. With us, you will find assignments that require curiosity, solution-driven approaches, and sharp expertise, 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.

As a Regulatory Affairs consultant with us, you will become a key person for our clients. You will support them throughout the product lifecycle – from development and clinical evaluation to market access and post-market. You will have ample opportunity to influence your own development and the chance to lead or participate in projects that make a real difference.

Your responsibilities will include: - Designing regulatory strategies and guiding clients through complex regulations (EU MDR/IVDR, FDA, MDSAP, etc.). - Working with regulatory applications, submissions, and interactions with authorities and notified bodies. - Ensuring accurate and complete technical documentation. - Contributing to clinical and performance evaluations as well as 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.

This is how you will shine:

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 Regulatory Affairs within medical technology or IVD. - A degree from a university or college in Life Science (e.g., engineering, BMA, or PhD). - 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. - Standards for risk management, safety, and performance (ISO 14971, IEC 60601, IEC 62366, ISO 15189). - Technical documentation and clinical/performance evaluation. - Excellent language skills in Swedish and English.

It is also a merit if you have any of the following:

• Experience in QA-related areas such as quality systems, audits, or CAPA.

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

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

We welcome you to submit your application as soon as possible. Selection and interviews are ongoing.

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 career page and indicate that you are interested in working as a subcontractor – we will get back to you when something suitable comes up.