Regulatory Affairs & Qa Specialist

REGULATORY AFFAIRS & QA SPECIALIST

Join the NEOMEDICA team - Innovation in the pharmaceutical industry

NEOMEDICA, a global leader in the production of clinical laboratory reagents and devices, is hiring a Regulatory Affairs Specialist who is an essential member of the Quality Assurance Department working to maintain the company's global product portfolio, who will work closely with other departments to adapt processes and meet specific regulatory requirements, in accordance with applicable standards and Good Manufacturing Practices.

HERE’S WHAT YOU’LL BE DOING:

• Research global regulatory requirements and streamline processes for efficiency
• Monitor changes in regulatory requirements for domestic and international
• Actively participate in internal and external audits to ensure successful compliance and timely corrective actions.
• Handle global documentation requests and communicate with partners and stakeholders on various projects.
• Collaborate with all departments to integrate regulatory requirements throughout the product lifecycle
• Provide general support to the department by maintaining/creating files (hard and soft copies)
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WHAT WE ARE LOOKING FOR:

• University degree in Pharmacy, Electronics Engineering, Biomedical Engineering, Technology, Biology, Medicine, or related fields.
• Fluent English: Required for daily communication and work on international projects
• Skills: High precision, strong analytical skills, and a collaborative mindset. Detail-oriented and able to manage multiple projects simultaneously
• Proven experience with ISO 13485, ISO 9001, and Medical Device Regulations, including CE mark compliance and technical documentation is preferred

BENEFITS:

• Work in a dynamic, innovative, and supportive environment
• Opportunity for long-term career growth and professional development
• Exposure to global markets and international regulatory standards
• Continuous professional training and education

HOW TO APPLY:

Submit your CV, motivation letter in English (certificates and additional references are preferred)