Compliance Learning Specialist

Job Role: Compliance Learning Specialist

Location: Skopje, Macedonia

Reporting to: Learning & Development Manager

Established in 1984, MAK-SYSTEM’s vision is to design, develop, and deliver globally best-of-breed software to manage Blood, Plasma, Tissue, and Cells from end to end using the best technologies and functionalities for the patient’s benefit. Our software solutions continuously support the digital transformation of organizations such as

• Blood Centers
• Plasma Centers
• Transfusion Services
• Tissue Banks
• Stem Cell Labs
• Cell and Gene Therapy (SME to Big Pharma, CMOs, Hospitals)

The Compliance Learning Specialist is responsible for the design, implementation, and oversight of compliance-related learning programs, ensuring all employees are trained and assessed on regulatory, QMS, ESG, and cyber security requirements. It also owns key systems like LMS and KM Portal, maintains audit readiness, and ensures learning processes align with corporate and regulatory standards.

Key Responsibilities

• SME for compliance learning needs. Own and implement compliance sections of Learning Profiles and Competency Assessments
• Responsible for all MAK employees being trained on compliance requirements including QMS, Regulatory, Cyber and Corporate ESG training, ensuring all necessary artifacts and evidences are gathered
• Create training, deploy and assess competency on MAK specific compliance requirements (ie SOP)
• Source, deploy and assess competency on non-MAK specific compliance requirements (ie ESG)
• Responsible for the Learning SOP and processes, ensuring they are in compliance with the MAK-SYSTEM QMS
• Respond to any customer, regulatory or other audits relating to training
• Ensure all job descriptions, career frameworks and learning profiles accurately reflect Compliance Competency Needs
• Own the KM Portal and ensure content is relevant and updated.
• Owns the LMS, ensure accurate data and necessary compliance artifacts

Objectives

• Audits satisfactorily passed
• Compliance Learning Effectiveness KPIs met

Previous Experiences/Qualifications

• Experience working within a regulated industry in Quality Assurance (preferably medical device or pharma) 
• Experience with quality standards, such as ISO 9001 
• Have excellent written, oral, and presentation skills in English 
• Continuous Improvement mindset
• Rolls up your sleeves and getting things done.
• Demonstrated ability to juggle multiple priorities
• Planful and well organized, able to manage a set of activities over a 3-6 month timeframe. 
• Collaborative and relationship builder. Strong team player
• Good data orientation, using metrics to evaluate success