Regulatory Compliance Officer – IGT Systems

The Company
Our client is one of the top global technology companies known for its innovations in healthcare technology, consumer electronics, and lighting. Founded in 1891, it has originally started as a manufacturer of light bulbs but has since evolved into a leader in medical technology and health solutions.

Role Description
As a Regulatory Compliance Officer, you play a key role in ensuring that IGT systems meet all mandatory international and national regulations, including MDR and healthcare processes. You’ll work closely with cross-functional development teams to develop and execute standards and compliance plans

Responsibilities

• Define applicable standards and regulations (e.g., IEC 60601 series, IEC 62304, IEC 62366-1, EU MDR) for product development.
• Create and execute Standards and Compliance plans, ensuring all legal requirements are met and documented for product certification.
• Collaborate with designers and testers to interpret and implement standards and regulations for IGT product design.
• Support the Regulatory Affairs department with technical insights for submissions to regulatory bodies.
• Secure product certification by independent certifying agencies and ensure compliance evidence is complete.

Requirements

• Bachelor’s degree or higher in a technical field, health sciences, or related.
• 3-5 years of experience in software/hardware testing or engineering in a complex environment.
• Experience in the medical devices industry is a strong advantage.
• Familiarity with IEC 60601 product safety standards and international regulations.
• Strong project management and team collaboration skills.
• Experience in audits and continuous improvement initiatives is preferred.

• Standards: IEC60601-1 series, IEC 62304, IEC 62366-1, EU MDR, 21 CFR 820.
• Knowledge of artificial intelligence standards and regulations is a plus.

Other Information

• If you think this role is for you and you want to explore more of the possibilities, please contact Leri Salve Lapore and apply via the button below.

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