Informacje o stanowisku

About Us At MIM Fertility, we automate and enhance the efficiency of in vitro fertility treatments through advanced AI solutions. For several years, we have been developing innovative diagnostic tools related to in vitro treatments, supporting patients with cutting-edge technology.

Who Are We Looking For? If you’re decisive, analytical, and passionate about precision, apply for the position of Regulatory/Compliance Officer . This role is pivotal in ensuring our products comply with international standards, directly impacting the growth of our company and the availability of modern medical technologies in global markets.

Requirements:

• A higher education degree (or current enrollment) in fields such as law, medicine, or pharmacy, along with at least 3 years of professional experience in regulatory affairs or quality management for medical devices, or at least 4 years of professional experience in regulatory affairs or quality management for medical devices.
• Experience with MDR and FDA certifications, preferably related to software as a medical device (SaMD).
• Proven expertise in working with SaMD (Software as a Medical Device).
• Experience in certifying medical devices for small businesses.
• Proficiency in English (C1 level, written and spoken).
• Analytical mindset and ability to collaborate in a technical environment.
• Knowledge of ISO 13485, ISO 14971, and IEC 62304 standards.

Should Have

• Experience in the cybersecurity industry.

Nice to Have

• Experience working with software as a medical device.
• Certifications related to risk management or regulatory compliance (e.g., RAC).

Duties

• Developing and supervising technical documentation in compliance with MDR (EU), FDA (USA), and other regulations.
• Collaborating with product teams to assess the compliance of software as a medical device.
• Managing certification processes for European, U.S., and other markets.
• Monitoring regulatory changes and implementing them within the organization (e.g., MDR updates, 21 CFR Part 820).
• Coordinating activities related to internal and external audits (e.g., notified body audits, FDA audits).
• Managing regulatory compliance risks at every stage of the medical device lifecycle.

We offer:

• The opportunity to work in a modern company whose products have the potential to impact millions of patients worldwide.
• A development path toward becoming an expert in medical device certification.
• Opportunities to participate in international projects and conferences.
• Access to industry-specific training (MDR, FDA, ISO).
• Flexible working conditions (on-site or hybrid: 2–3 days in the office) with adjustable working hours (core hours from 10:00 AM to 3:00 PM).
• An office in a convenient location in Warsaw’s Ochota district, offering an environment conducive to work and conversations over great coffee.
• Openness to your ideas and “bottom-up” solutions.
• Benefits package: MultiSport card, MultiLife, and private health insurance (Medicover).

If you’re passionate about medtech and thrive in a dynamic startup environment, send us your CV.

If you want to join our team, please send your CV to the following e-mail address: or use the form below

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Warszawa - Oferty pracy w okolicznych lokalizacjach