Jobs in Stockholm, Sweden

About the role

We are seeking a regulatory affairs professional to work with our medical devices in our portfolio of cardiology devices and applications. Depending on experience, the position may be hired as either an RA Engineer or RA Engineering Lead, both reporting to the RA Manager. You will work closely with engineering, clinical, product and project management teams to support regulatory activities across the product lifecycle. The role covers both hardware devices and software as a medical device (SaMD), with strong focus on EU MDR technical documentation, FDA submissions, post-market activities and regulatory guidance during development. This role is suited for someone who is hands-on, comfortable working cross-functionally, and able to apply regulatory requirements pragmatically in a fast-moving development environment. We are seeking a regulatory affairs professional to work with our medical devices in our portfolio of cardiology devices and applications. You will work closely with engineering, clinical, product and project management teams to support regulatory activities across the product lifecycle.

What you'll bring

• · BSc or MSc degree within law, medicine, pharmacy, engineering, or another relevant scientific discipline; or equivalent professional experience.
• · At least 3 years of professional experience in regulatory affairs or quality management for medical devices.
• · Working knowledge of EU Regulation 2017/745 (MDR), FDA 21 CFR (including QSR), UK MDR, ISO 13485, ISO 14971, IEC 60601-1 series, IEC 62304, and other applicable standards.
• · Experience with regulatory submissions and direct communication with authorities and Notified Bodies across international markets.
• · Excellent analytical skills, able to interpret complex regulatory requirements and provide risk-based, practical recommendations.
• · Strong writing and communication skills
• able to give clear direction to development teams and engage credibly with external stakeholders.
• · Highly self-motivated
• able to manage multiple workstreams independently and with minimal supervision.
• · Fluent in English (oral and written).
• · Experience with cardiovascular, cardiac monitoring, or electrophysiology medical devices.
• · Proficiency in Swedish.