Regulatory Affairs Manager

Cosylab develops software for medical devices used in radiation therapy. These are our own products: we develop them and manage the certification activities ourselves. We are looking for a Regulatory Affairs Manager t…

  • Employer: Cosylab d.d.
  • Location: Ljubljana
  • Employment type: Full-time
  • Work mode: HYBRID
  • Posted:
  • Apply before:

Job description:

- Cosylab develops software for medical devices used in radiation therapy. These are our own products: we develop them and manage the certification activities ourselves. We are looking for a Regulatory Affairs Manager to strengthen the team that brings them 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. You will do this together with our Quality Office and with product management, which includes our systems engineers and medical physicists.

- The 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.

- Identify and interpret the regulatory requirements that apply to our products in our target markets and turn them into concrete input for development and documentation.

- Create and maintain the technical documentation for our products across their lifecycle, and keep it audit-ready.

- Prepare, submit and follow up regulatory submissions and product registrations, and handle questions from authorities and notified bodies.

- Plan the regulatory pathway for new versions and features together with product management and advise early on the impact of proposed changes.

- Work with systems engineers and medical physicists on risk management, usability and clinical evaluation.

- Support post-market surveillance and vigilance activities, including trending, periodic reporting and reportability decisions.

- Support internal and external audits and follow findings through to closure.

- Monitor changes in regulations, standards and guidance for medical device software, and advise the teams on what they mean in practice.

- 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, and in keeping it consistent as product evolves.

- Ability to work closely with software engineers, systems engineers and physicists, and to translate regulatory requirements into terms they can act on.

- 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.

- Education

- B.Sc. in Computer Science, Electrical Engineering, or other related technical disciplines.

- Bonus points if you 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 …

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