Medical Device Manager

LINK Medical Research AB; Stockholms län; On-site; SEK 600 000 - 800 000; Full time

Job summary

A leading clinical research organization in Sweden is seeking a Medical Device Manager to develop and execute regulatory strategies for medical devices and software solutions. The ideal candidate will have a Bachelor's degree and 2-3 years of experience in the medical device sector. Excellent software skills and proficiency in ISO standards are essential. The role offers competitive compensation and a collaborative work environment.

Benefits

Competitive compensation

Continuous development opportunities

Collaborative work environment

Qualifications

• Minimum bachelor’s degree in science or engineering.
• At least 2-3 years of experience in medical device or in-vitro diagnostics.
• Excellent software skills for regulatory documentation.

Responsibilities

• Develop regulatory strategies for Medical Devices.
• Guide clients on quality systems according to ISO 13485.
• Prepare documentation for European regulatory requirements.

Skills

Experience in medical device industry

Regulatory knowledge (ISO 13485, MDR)

Software skills for regulatory documentation

Team project management

Fluency in English

Education

Bachelor's degree in science or engineering

Job description

This position is open at our offices in Stockholm or Uppsala, Sweden.

Our company is growing, and the portfolio of cross-functional projects is increasing. As a Medical Device Manager, you will work in close collaboration with members of several project teams and members of the Medtech Group across the LINK Medical organization.

We are looking for a proactive and detail-oriented Medical Device professional to support startup companies in the MedTech and In-Vitro Diagnostics sector, where the solutions involve software and AI. This role is designed for someone who thrives in dynamic environments and enjoys being a trusted partner for early-stage businesses.

Responsibilities

Develop and execute regulatory strategies and development plans for Medical Devices, Software and AI as a Medical Device and In Vitro Diagnostics.

Guide clients in implementation of quality systems according to ISO 13485.

Prepare documentation in accordance with European (CE marking, MDR) requirements for Medical Devices and/or In Vitro Diagnostics.

Guide clients in processes of Design Control and Risk Management (ISO 14971) for Medical Devices.

Desired qualifications

• Minimum bachelor’s degree in science or engineering
• At least 2-3 years of experience in medical device or in-vitro diagnostics industry, preferably with software and AI
• Excellent software skills to support design development and regulatory technical documentation for software/AI medical- or in-vitro diagnostic devices
• Experience with regulatory work and quality systems according to ISO 13485
• Very good knowledge of regulatory requirements of MDR or IVDR and ISO standards such as ISO 13485, ISO 14971 etc.
• Ability to work on projects in a team and as a project leader
• Fluent in English (written and oral)

Personal characteristics

• Driven and show initiative
• Good communication skills
• Well organized, structured and solution oriented
• Ability to work independently and flexible in a fast-paced environment

LINK Medical offers

We offer an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given engaging assignments requiring efficient collaboration with industry partners, clinical and scientific teams and the regulatory authorities. We offer a competitive compensation and benefit scheme for all employees.

Last day for submitting your application:

2025-12-01.