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. Exciting assignments that thrill await you – assignments that require curiosity, sharp minds, and a willingness to find solutions where others see challenges. The variety in our projects means you will constantly develop and put your skills to the test in new contexts. At the same time, you will contribute to something greater.

Through our work, we help shape tomorrow's solutions – we make a difference for people, society, and the future. All of this we do together, in teams filled with some of the industry's most skilled and experienced colleagues. Here, we inspire each other, share knowledge generously, and drive development forward – with quality, curiosity, and sharpness as our common foundation.

This will be your role

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 role includes, among other things: - Designing regulatory strategies and guiding clients through complex regulations (EU MDR/IVDR, FDA, MDSAP, etc.). - Working with regulatory submissions and interactions with authorities and notified bodies. - Ensuring correct 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 implementation.

To succeed in this role, you have:

- At least 3 years of experience in Regulatory Affairs within medical technology or IVD. - A bachelor's or master's degree in Life Science (e.g., engineering, BMA, or PhD). - Documented experience in one or more of the following areas: - EU MDR/IVDR and related 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). - Technical documentation and clinical/performance evaluation. - Very good language skills in Swedish and English.

It is also an advantage if you have any of the following:

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

Being part of Team PV

We are a consulting company passionate about being part of Life Science in Sweden. From the small startup in MedTech to the global pharmaceutical giant and everything in between. This means an opportunity to follow the entire chain – from manufacturing to use in healthcare – and work with everything from regulations and audits to project management, standards, and evaluations. Helping our clients achieve their goals is what drives us. So, if you want to be part of something bigger, something that makes a real difference and can ultimately save lives and secure patients – then you have come to the right place. With us, some of the industry's sharpest minds work, and as part of Plantvision Compliance, you will become an incredibly important cog in our ongoing effort to make a difference. For real.

Awards and accolades are not everything, but we are proud to be a certified Great Place To Work company (for the tenth year in a row, in fact), which means we are one of the best employers in Sweden. With us, you get something different. We stand out from traditional consulting firms through our unique culture, which permeates everything we do. Inclusive, supportive, and developmental. We see you. You and your colleagues are, after all, the most important thing we have.

Together we can move mountains. Today, tomorrow, and beyond.

Application

We welcome you to submit your application as soon as possible. Selection and interviews are ongoing, and the position may be filled before the application deadline, which is November 30.

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 subcontractor?

Instead of applying for a specific position, please connect with us via our career page (https://plantvision.se/karriar/) and indicate that you are interested in working as a subcontractor – we will get back to you when something suitable comes up.