Job Description

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.

Note: The selected candidate will be employed by and sign the contract with an external third-party company.
注：录用者将与指定的第三方公司签订合同。

The Regulatory Operation Specialist supports regulatory operation activities, including management of regulatory documentation and information as well as optimization of relevant systems and processes. The role ensures compliance with applicable medical device regulations, ISO 13485, and Getinge’s Quality Management System (QMS) with the objective of improving efficiency and effectiveness of regulatory compliance activities.

Job Responsibilities and Essential Duties
• Main responsibilities (85%)
 Manage the archiving and release of regulatory documentation, including but not limited to archiving in required locations and computer systems and controlled distribution to non-QRC functions;
 Manage the timely and compliant release, maintenance and updating of regulatory information such as regulatory approvals, regulatory labelling data and UDI data;
 Ensure regulatory records are complete, accurate, traceable, and audit-ready;
 Support internal and external audits, including ISO 13485 audits, notified body assessments, and regulatory authority inspections, as needed;
 Prepare audit and inspection evidence packages and support tracking and closure of related CAPAs;
 Collaborate with cross-functional teams on regulatory operations–related projects and initiatives;
 Support the line manager in continuous improvement initiatives aimed at enhancing regulatory operations processes and efficiency.
• Other tasks (15%)
 Complete other tasks assigned by line manager in a timely manner

Minimum Requirements
• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, information management and data statistical analysis is preferred;
• 2+ years of experience in Regulatory Affairs, Regulatory Operations, or Quality Systems within a medical device or regulated life science environment.
• Experience in working under an ISO 13485-certified Quality Management System.
• Fluency in English (written and spoken)

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.