We’re Hiring — Join Us
The Regulatory & Quality Management Track
Inviting the dedicated professionals to Build an Exceptional Future Together
About Success Link
We are a professional consulting and service company focused on medical devices, in vitro diagnostic reagents (IVD), pharmaceuticals, and biological products. We are dedicated to providing clients with one-stop solutions spanning regulatory registration, quality management system establishment and certification, and third-party auditing.
Our team consists of experienced, highly skilled technical professionals serving numerous well-known medical enterprises both domestically and internationally. Driven by rapid business growth, we are now expanding our team and welcoming dedicated professionals to join us in advancing the high-quality development of the medical products industry.
Position: Registration Manager
(Medical Devices / Pharmaceuticals / Biological Products)
Join Success Link’s Regulatory & Quality Management Track as Registration Manager. Lead multi-country approvals and shape global medical product compliance.
Job Responsibilities
- Design overseas registration pathways, conduct upfront compliance risk assessments, and develop integrated market entry strategies for multi-country coordination (familiar with one or more areas of medical device, pharmaceutical, or biological product registration).
- Develop project implementation plans and oversee the execution of multi-country simultaneous registration projects, including but not limited to EU CE/MDR, US FDA, China NMPA, and WHO PQ.
- Provide in-depth guidance to clients on building product technical systems(such as DHF,etc.), comprehensively review all submission dossiers, identify key compliance risks, and deliver systematic solutions.
- In-depth communication with the regulatory authorities ensures the smooth progress of product registration.
- Lead the improvement of project processes and standardized templates, and conduct regulatory research and in-depth analysis of key regions.
- Track global regulatory updates and industry trends, study regulatory differences across countries and regions, and produce professional regulatory analysis reports.
- Provide technical guidance to the team, accumulate project experience, and elevate the overall professional capabilities of the team.
Qualifications
- Bachelor’s degree or above in biomedical engineering, pharmacy, medicine, biotechnology, or related fields.
- 10+ years of experience in registration projects for medical devices, pharmaceuticals, or biological products, with deep understanding of regulations such as EU MDR/IVDR/EMA, US FDA, China NMPA, and WHO PQ.
- Experience in managing registration teams, capable of leading teams to handle batch registration projects with clear task allocation and coordination.
- Familiar with the full registration process for one or more of the following: Class II(a) and above high-risk medical devices, active implantable devices, IVD, biological products, or pharmaceuticals. Has independently led complex cross-border registration projects.
- Excellent risk assessment and problem-solving skills, with strong client communication and cross-departmental collaboration abilities.
- Proficient in English ; able to independently prepare English registration dossiers and communicate with regulatory authorities.
- Willing to travel domestically and internationally.
What We Offer
- Competitive compensation package (base salary + performance bonus + project bonus)
- Social insurance & housing fund + paid annual leave + holiday benefits
- Comprehensive training system and clear career advancement paths
- Opportunities to work on global projects, engage with international regulatory systems, and expand high-end industry networks
- Access to an internal regulatory knowledge base with full technical support from senior experts
- Flat management structure with an open, inclusive team culture
How to Apply
Email: 953295217@qq.com
Email subject format:
Track – Position – Name
(Example: Regulatory Track – Registration Manager – Zhang San)
We look forward to working with you to deepen the global compliance landscape and bring high-quality medical products to every corner of the world.