Arbetsbeskrivning

Picture yourself at one of the best places to work, surrounded by teams and people who challenge you, support you, and inspire you to be extraordinary. GBA Key2Compliance offers more than a job. We offer limitless opportunities to make a difference for our customers and improve patient safety. Join us today!

Clinical Evaluation Consultant

As a Clinical Evaluation Consultant, you will play a key role in delivering high‑quality, MDR‑compliant clinical documentation that enables our clients to bring safe and effective medical devices to market. You will lead and execute clinical evaluation activities across a variety of device classes, supporting manufacturers with robust scientific analyses and clinical strategy.

You will collaborate closely with cross‑functional teams, including regulatory affairs, quality assurance, R&D, risk management, and post‑market surveillance, to ensure that clinical evidence is accurate, compliant, and aligned with both regulatory expectations and device‑specific needs. Your ability to manage projects, perform systematic literature reviews, and communicate clearly with stakeholders will be central to success in this role.

Your work directly contributes to the safety and performance of medical devices and strengthens our position as a preferred partner for clinical and regulatory support within the life science industry.

Your responsibilities

•In collaboration with internal teams and clients, plan, coordinate, and write MDR‑compliant Clinical Evaluations, to ensure timely and compliant delivery of all clinical evidence documentation.

• Stay up to date with regulatory guidelines, standards, and best practices within clinical evaluation.

• Communicate effectively with Notified Bodies and support clients during regulatory interactions.

• Contribute to continuous improvement of templates, procedures, and working practices.

• (Senior-level consultants) Mentor colleagues, share expertise, and help build internal capability in clinical evaluation.

Who you are

You are experienced within clinical evaluations, systematic literature reviews and medical writing within the medical device industry. You are confident planning and producing MDR‑compliant clinical documentation and have strong analytical skills supported by a solid scientific foundation.

You have experience working with multiple stakeholders and navigating complex regulatory environments. You communicate clearly, work in a structured way, and enjoy transforming scientific data into high‑quality, regulatory‑ready deliverables. Experience from interaction with Notified Bodies and Class I–III devices (including implantable and software-based technologies) is highly advantageous.

You are fluent in English, both spoken and written. Swedish is an advantage but not a requirement for this role.

A PhD or MSc in a relevant life science field is beneficial.

Why GBA Key2Compliance?

Working at GBA Key2Compliance means making a meaningful impact every day. Your expertise directly strengthens our clients' clinical and regulatory capabilities and ultimately enhances patient safety. You will be part of a highly skilled team that values collaboration, knowledge‑sharing, and continuous learning.

We offer a supportive, low‑prestige environment with a mix of structure and entrepreneurial spirit — a place where you can grow professionally while contributing to work that truly makes a difference.

Practical information

Workplace: Stockholm, Gothenburg or Lund

Travel: May occur occasionally depending on client needs

Hybrid work: Possible depending on operational requirements