(Senior) RA Specialist

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. Job Overview This role is responsible for planning and implementing product registration and lifecycle maintenance activities in the Hong Kong and Macao markets, as well as other tasks assigned by line manager. Job Responsibilities and Essential Duties A. Regulatory Affairs (75%) Collaborate closely with global and local teams to develop and implement regulatory strategies for assigned projects. Prepare, coordinate, and submit regulatory applications to the local health authorities to ensure timely approvals. Review product change assessment requests and take actions accordingly to ensure regulatory compliance and secure business continuity. Provide regular updates to internal stakeholders on product registration progress and regulatory trends affecting Getinge products. Maintain and organize regulatory records, including submission dossiers, product licenses, and related communications. B. Others (25%) Support SSU QRC activities, such as internal/external audits. Other responsibilities as directed by line management. Minimum Requirements Bachelor’s degree or above in Biomedical Engineering, Medical Sciences, Biotechnology, or a related science/engineering field. 2-4 years’ experience in product registration or QMS in the medical device Industry. Work experience in MNC is highly preferred. Proven track record in regulatory submissions in Hong Kong, including new listings and product changes. Solid understanding of medical device regulations and applicable requirements in Hong Kong and Macao markets. Good internal/external communication skills, good interpersonal skills. Basic understanding / willingness to learn medical device registration processes, QMS requirements to support compliance with ISO 13485 / ISO 9001. Independent with strong self-initiative Good command of written and spoken English and Chinese; Cantonese preferred 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.