Senior Regulatory Affairs Manager

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
Lead the planning and implementation of assigned product registration projects in China to ensure timely approval and regulatory compliance; Lead regulatory intelligence process to ensure timely detection and communication to relevant stakeholder; Support strategic initiatives such as M&A from regulatory perspective; Team management/development; Others.

Job Responsibilities and Essential Duties
A.    Product market authorization (30%)
-    Collaborate closely with global and local teams to develop and implement regulatory strategies for assigned projects.
-    Oversee the end-to-end premarket registration process, ensuring timely preparation, submission, and approval by Chinese regulatory authorities.
-    Ensure regulatory decisions support sustainable product lifecycle management and post-market regulatory compliance.

B.    Regulatory intelligence (25%)
-    Establish and maintain a systematic process to monitor and analyze the evolving regulatory landscape in China, facilitate structured discussions to assess impacts, and ensure timely and actionable communication to all relevant stakeholders.
-    Represent in interactions with regulatory authorities, industry associations, and working groups to support advocacy initiatives aligned with company priorities. 

C.    Regulatory support for strategic initiatives (15%)
-    Provide regulatory strategy support for planning and implementation of strategic initiatives, including M&A.

D.    Team management and capability development (20%)
- Build and develop a high-performing regulatory team through coaching, training, and talent development.

E.    Other responsibilities as directed by line management (10%)

Minimum Requirements
•    Bachelor’s degree or higher in Life Sciences, Engineering, Pharmacy, or a related field.
•    A minimum of 10 years’ experience in Regulatory Affairs field of the medical device Industry.  Work experience in MNC is highly preferred.
•    Proven track record in regulatory submissions in China (NMPA, NHC, etc.), including new product registrations and product changes.
•    Experience in leading regulatory projects, managing internal cross functional stakeholders, and interacting with regulatory authorities.
•    Solid understanding of China medical device regulations and applicable standards.
•    Experience in building, managing, and mentoring a team.
•    Proficiency in written and verbal English and Chinese, with strong ability to interpret regulatory requirements and communicate them effectively.

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.