Quality Regulatory Compliance Specialist

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Quality Assurance and Regulatory Affairs professional with experience supporting medical device compliance across product registration, QMS operations, and regulatory reporting. Skilled in monitoring regulatory changes, maintaining ISO 13485-aligned quality systems, managing document control, and supporting audits, CAPA, and continuous improvement initiatives. Experienced in FSCA coordination, adverse event reporting, and preparation of product registration and licensing submissions. Builds strong partnerships with internal teams and regulatory authorities to ensure compliant, timely market access and uphold patient safety and product quality.

Job Responsibilities and Essential Duties

Quality Assurance (QA)

• Assisted QRC Manager in monitoring regulatory changes, new legislation, and applicable standards impacting product registration and QMS.
• Tracked country‑specific regulatory requirements and provided timely regulatory intelligence on current and upcoming regulations and guidelines.
• Maintained and implemented Global Sales QMS requirements at the country level; developed local procedures to meet local regulatory needs.
• Served as Document Controller, managing all quality and regulatory documentation aligned with applicable QMS standards.
• Supported QMS activities including monthly KPI reviews, internal/ external audits, process reviews, continuous improvement initiatives, CAPA, and complaint handling.
• Collected, filed, and maintained documentation related to FSCA, adverse event reporting, supplier management, and other QRC matters.
• Coordinated with Sales & Service Unit teams to ensure execution of Field Safety Corrective Actions in accordance with local regulations and global SOPs.
• Managed adverse event reporting to local regulatory authorities and ensured timely status updates through TrackWise.
• Fostered professional working relationships with local regulatory authorities.
• Performed additional duties as assigned by the company or line manager.

Regulatory Affairs (RA)

• Compile and prepare product registration packages and other relevant licenses application, change notifications, renewals
• Ensures timely update of product registration details in databases in a compliant and timely manner

Minimum Requirements

• Bachelor's degree in science background or related field.
• 1-5 years of experience in Medical Device, Pharmaceutical or related field.

Required Knowledge, Skills and Abilities

• Knowledge of registration process and/ or DCC for any applicable QMS is a must.
• Fluent in English both written and spoken.
• Good computer literacy (MS Office, sharepoint, MS Teams etc).
• Good coordinator, relationship, and communication skill with other departments
• Good interpersonal skills and service orientation.
• Ability to do multi-tasks & manage priorities under pressure.

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.