Regulatory Lead - Medical Device Software

Do you want to be the regulatory voice behind software that is changing how cancer is treated around the world? RaySearch is looking for a Regulatory Lead who combines deep EU MDR expertise with strategic thinking – someone who wants real ownership and the chance to shape a product all the way from early development to the market. Your role Responsibilities As Regulatory Lead, you are the regulatory point of contact for one or more RaySearch products. You work closely with Development, Corporate Strategy and Sales. You help shape product strategy, guide development, drive market access and ensure compliance throughout the product lifecycle. This is a highly visible role with real influence, where your advice helps shape both product and business decisions. Your main responsibilities include:

• Owning the EU regulatory strategy for the product while keeping oversight of global submissions, registrations and market access
• Leading the preparation, review and lifecycle management of EU MDR Technical Documentation and EU regulatory submissions
• Acting as the regulatory expert in development projects and making sure regulatory requirements are built into design and development
• Partnering closely with Development teams to guide regulatory and compliance decisions throughout the product lifecycle
• Advising senior stakeholders and supporting key product and business decisions
• Coordinating multiple projects and submission timelines while keeping the long-term product roadmap in view
• Providing regulatory input to vigilance activities and leading product-specific assessments for trend monitoring, PSURs and CAPA
• Supporting inspections, audits and continuous improvement

Your background

• A Bachelor’s or Master’s degree in Engineering, Life Sciences, Biomedical Engineering or a related field
• Several years of Regulatory Affairs experience in the medical device industry
• Strong experience preparing and reviewing Technical Documentation under EU MDR
• Experience with medical device product development and design control processes
• Experience with Software as a Medical Device (SaMD) or medical device software
• Strong knowledge of IEC 62304 and ISO 14971
• Strong project and stakeholder management skills, with the ability to handle several timelines without losing the bigger picture
• Very good command of English, both written and spoken

It is meriting if you have US regulatory experience, including FDA submissions such as eSTAR/510(k). Experience with IEC 62366, IEC 60601 and ISO 14155, with cybersecurity requirements for medical devices, or with AI/ML-enabled medical devices is also meriting. You are proactive and pragmatic, and you enjoy taking ownership and driving things forward. You are technically strong and comfortable working with development teams. You can translate complex regulatory requirements into practical solutions. You like having the full product picture, from early strategy to submission and post-market, and you thrive in a collaborative, fast-paced environment. RaySearch offers

• Real ownership in a highly visible role, where you own the regulatory strategy for a product that makes a difference for cancer patients worldwide
• Close collaboration with dedicated experts in Development, Corporate Strategy and Sales, and a seat at the table when key product and business decisions are made
• A modern office in Hagastaden, Stockholm’s Life Science Hub, with an in-house gym, yoga classes, a lunch buffet, daily fika and a rooftop terrace with a 360-degree view of Stockholm
• A competitive compensation and benefits package

Application RaySearch is working with Compass on this recruitment. Selection is ongoing, so please apply as soon as possible via this link: https://pnty-apply.ponty-system.se/compass?id=2298 For questions, you are warmly welcome to contact Compass’s consultants: Erik Düring, Senior Consultant, +46 70 899 94 69, erik.during@compass.se Jens Nordqvist, Head of Research, +46 70 145 35 69, jens.nordqvist@compass.se