About this role
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: This is a two-year contract position. The selected candidate will be employed by and sign the contract with an external third-party company. 注：此职位为两年期合同岗，录用者将与指定的第三方公司签订合同。
- Job Overview Coordinate and execute regulatory activities in China related to the EU MDR uplift; manage end-to-end registration and regulatory projects for assigned products to ensure timely approval and compliance; support regulatory handover, documentation, and system management; provide regulatory guidance to business and cross-functional stakeholders; and perform other responsibilities as assigned by line management. ; Others.
- Job Responsibilities and Essential Duties A . Regulatory strategy and registration activities (45% ) - Develop and implement China regulatory strategies for assigned products and projects based on applicable regulatory requirements, product lifecycle plans, and business needs. - Manage the end-to-end registration process, including regulatory pathway assessment, registration planning, dossier preparation and submission, authority communication, deficiency response, and approval. - Collaborate with global and local stakeholders to identify regulatory risks, assess impacts, and define appropriate regulatory actions.
- B. Regulatory project management (30%) - Coordinate and execute China regulatory activities related to EU MDR uplift projects, ensuring alignment with global project plans and China regulatory requirements. - Manage project timelines, milestones, deliverables, risks, and dependencies, and drive cross-functional follow-up and issue resolution. - Prepare monthly regulatory updates to communicate project status, key risks, and required actions to relevant stakeholders.
- C. Other operations and execution (15%) - Manage post-registration documentation and archiving, coordinate with Quality and manufacturing sites on product CSL , and support other documentation and administrative activities. - Support regulatory systems and data management by providing user guidance, maintaining data quality, and improving related processes.
- D. Other responsibilities as directed by line management (10%) - Perform other regulatory activities and responsibilities as assigned by line management to support functional and business priorities.
- Minimum Requirements Bachelor’s degree or higher in Life Science s , Engineering, Pharmacy, or a related field A minimum of 6 years of regulatory affairs experience in the medical device industry; experience working in a multinational company is highly preferred.
- Solid understanding of China medical device regulations and applicable standards.
- Proven track record in regulatory submissions in China, including new product registrations and product changes.
- Required Knowledge, Skills and Abilities Proficiency in written and verbal English and Chinese.
- Experience in new product registrations and change registrations for both active and non-active medical devices.
- Experience in managing EU MDR uplift-related regulatory activities in China is highly preferred.
- Strong project management skills, with the ability to manage multiple priorities, timelines, risks, and cross-functional dependencies.
- Demonstrated ownership and the ability to collaborate effectively with global and local cross-functional stakeholders.
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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.