Regulatory Affairs Consultant in Medtech/IVD

Description:

Do you want to help ensure quality in Life Science alongside the industry's sharpest minds? Then this is where you belong. With us, you'll find assignments that require curiosity, a drive to solve problems, 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. Your Role As a Regulatory Affairs consultant with us, you'll become a key person for our customers. You'll support them throughout the entire product lifecycle—from development and clinical evaluation to market access and post-market activities. You'll have significant scope to influence your own development and opportunities to lead or participate in projects that make a real difference. Your responsibilities will include: - Developing regulatory strategies and guiding customers through complex regulations (EU MDR/IVDR, FDA, MDSAP, etc.). - Working with regulatory submissions, applications, and interaction with authorities and notified bodies. - Ensuring correct and complete technical documentation. - Contributing to clinical and performance evaluation as well as implementation of 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. Where You'll Excel You have the ability to make complex regulatory requirements understandable and build trust through your communicative style. You're thorough, 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 devices or IVD. - A degree from a university or college in Life Science (e.g., M.Sc. in Engineering, BMA, or PhD). - Documented experience in one or more of the following areas: - EU MDR/IVDR and associated guidance documents. - 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 as well as clinical/performance evaluation. - Excellent language skills in Swedish and English. It's also advantageous if you have experience in one or more of the following: - QA-related areas such as quality systems, audits, or CAPA. Part of Team PV We're a consulting firm passionate about Life Science, from MedTech startups to global pharmaceutical companies. With us, you'll follow the entire chain, from manufacturing to healthcare, and work with regulations, audits, project management, and evaluations. What drives us is helping customers reach their goals and making a real difference for patients and society. With us, you get something different. We stand out from traditional consulting firms through our unique culture, which is distinctive and permeates everything we do—and we're extremely proud to be a Great Place To Work, year after year. Some say culture lives in the walls. If ours did, we'd have soft walls. Welcome to us at Plantvision! Application We welcome your application as soon as possible. Selection and interviews take place on a rolling basis. 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're interested in working as a subcontractor—we'll get in touch when something suitable comes up.

Overview

Type

job

Status

active

Visibility

public

City

Kista

Address

Färögatan 33

GPS

59.401685711652, 17.946437208993copyopen in

Email

[email protected]

Phone

072 566 99 87

Views

4

Published

11. 3. 2026

Edited

21. 6. 2026

Specifications