Regulatory Affairs Specialist (Medical Devices)

About Us

Lmb SOFT d.o.o., based in Niš, Serbia, is the production and development site of Lmb Technologie GmbH in Schwaig, Germany. Together with Macopharma, both companies are part of the GMPi Group, a leading alliance in the field of blood donation and blood bank technologies.

Lmb designs and manufactures high-quality medical devices such as blood donation monitors, blood separators, tube sealers, and platelet storage systems, serving healthcare institutions and blood banks worldwide. To support our growing international regulatory operations and certification programs, we are looking for a Regulatory Affairs Specialist to join our team in Niš.

Your Role

As a Regulatory Affairs Specialist, you will be responsible for managing and maintaining the regulatory compliance of Lmb’s medical devices across international markets. You will collaborate closely with colleagues from Quality Management, R&D, and Production to ensure that products meet the requirements of the EU MDR 2017/745, ISO 13485, MDSAP, and relevant international authorities such as Health Canada and the U.S. FDA.

Your work will directly contribute to the successful registration, certification, and market approval of medical devices worldwide.

Main Responsibilities

• Prepare, compile, and maintain technical documentation (Technical Files / Design Dossiers) according to ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820, and MDSAP requirements.
• Support and coordinate registration activities for international markets, including FDA 510(k) submissions, Health Canada licensing (MDSAP), and other regional approvals.
• Communicate with notified bodies, competent authorities, and external consultants on regulatory topics.
• Monitor changes in global medical device regulations and assess their impact on existing products and documentation.
• Participate in MDSAP and MDR audits by supporting the preparation and presentation of regulatory documentation.
• Ensure labeling, IFU, and packaging are compliant with all relevant market regulations.
• Support post-market surveillance and vigilance reporting processes in cooperation with Quality Management.
• Review and approve marketing materials, product specifications, and change requests from a regulatory perspective.
• Maintain the company’s regulatory database and ensure accuracy and traceability of submissions and certificates.
• Provide regulatory guidance and training to internal teams to promote awareness and compliance with global requirements.
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Your Profile

• University degree in Biomedical Engineering, Regulatory Affairs, Pharmacy, Life Sciences, or a related technical or scientific field.
• At least 2–4 years of professional experience in Regulatory Affairs or Quality Assurance within the medical device industry.
• Strong understanding of EU MDR 2017/745, ISO 13485, MDSAP, and FDA 21 CFR Part 820.
• Experience with 510(k) submissions and Health Canada licensing is an advantage.
• Knowledge of risk management (ISO 14971) and usability engineering (IEC 62366) is beneficial.
• Excellent organizational skills and attention to detail in documentation management.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and AI tools.
• Fluent English (written and spoken); German or French is a plus.
• Team-oriented, structured, and proactive working style.

What We Offer

• A key position within an international medical device group (GMPi) recognized for quality and innovation.
• Collaboration with German and international colleagues across Lmb and Macopharma.
• Opportunity to work on innovative, life-saving medical devices used in blood donation and transfusion medicine worldwide.
• Long-term career growth and continuous training within an ISO 13485 and MDR 2017/745 certified organization.
• A professional and supportive working atmosphere at our modern facility in Niš.