Regulatory Affairs Manager

About the Position

Cosylab develops software for medical devices used in radiation therapy. We are looking for a Regulatory Affairs Manager to strengthen the team that brings our products to market. You will determine which regulatory requirements apply in each of our target markets and prepare and maintain the documentation and submissions that meet them. This role is open to candidates at different stages of their career. If you bring regulatory experience, you will shape our regulatory strategy from the start. If you are newer to the field, we will train you and give you the time to grow into it.

Responsibilities

• Identify and interpret the regulatory requirements that apply to our products in our target markets.
• Create and maintain the technical documentation for our products across their lifecycle.
• Prepare, submit and follow up regulatory submissions and product registrations.
• Plan the regulatory pathway for new versions and features together with product management.
• Work with systems engineers and medical physicists on risk management, usability, and clinical evaluation.
• Support post-market surveillance and vigilance activities.
• Support internal and external audits and follow findings through to closure.
• Monitor changes in regulations, standards, and guidance for medical device software.
• Work with our Quality Office on the quality management system and on the continuous improvement of our development and documentation processes.

Requirements

• Familiarity with the regulatory frameworks for medical devices in our target markets, such as the EU MDR 2017/745 and the US FDA regulations, and with ISO 13485.
• Familiarity with, or experience with, software as a medical device and the standards that apply to it, such as IEC 62304, ISO 14971, and IEC 62366.
• Experience in writing clear, concise, and comprehensive technical documentation.
• Ability to work closely with software engineers, systems engineers, and physicists.
• Structured and thorough, able to manage several parallel submissions and deadlines.
• Developed communication skills and an open mind for discussion and team collaboration.
• Fluency in spoken and written English.
• B.Sc. in Computer Science, Electrical Engineering, or other related technical disciplines.

Nice to Have

• Several years of experience in regulatory affairs or quality management in the medical device industry.
• Hands-on experience in preparing EU MDR technical documentation, or FDA submissions.
• Experience as, or eligibility to act as, a Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR.
• Experience with highly regulated projects - radiotherapy, medical imaging, or particle therapy in particular.
• Experience working with notified bodies, competent authorities, or auditors.
• Experience with the Medical Device Single Audit Program (MDSAP).
• Familiarity with cybersecurity expectations for medical device software (IEC 81001-5-1), or with AI-enabled device software.
• Experience with post-market surveillance and change management in a regulated environment.

We Offer

• Employment contract for an indefinite period with a six-month probationary period.
• A work environment with flexible working hours and a hybrid work model.
• Competitive and periodically updated salary tailored to your skills, experiences, and results.
• Company-funded licenses for leading AI tools (Claude Code).
• Interesting work full of challenges in an international working environment.
• Opportunities to work abroad.
• High-impact learning culture: regular in-house and external training sessions and a team of international professionals eager to help you grow.
• Many recreational after-work activities, additional health insurance (Specialists+), unlimited coffee, soft drinks, fruit, and other well-being goodies.
• Cosylab events (Teambuilding, New Year’s Party, Picnic … ).

About the Company

We are the leading software solutions provider for the world’s most complex, precise, and advanced systems, such as particle accelerators, large telescopes, fusion reactors, innovative medical devices, and cancer treatment systems. Our technology enables organizations to make scientific discoveries, offer the most cutting-edge cancer treatments, innovate in healthcare, and introduce clean fusion energy to future energy markets. Working at Cosylab is a great opportunity to discover genuine teamwork and collaborate with experts from the world’s most important research projects. We value and strive to achieve good interpersonal relationships and try to ensure the pleasant well-being of all our employees. We are friendly, proud to work together, and able to develop just about any solution we put our minds to.