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: Quality Management System Manager
(Medical Devices / Pharmaceuticals / Biological Products)
Join Success Link as Quality Management System Manager to lead ISO 13485, GMP, and global audits for medical devices and pharmaceuticals.
Job Responsibilities
- Plan, establish, implement, and continuously improve for the quality management systems of our clients(such as ISO 13485, GMP, MDSAP, and other quality management systems,etc).
- Organize the preparation and revision of quality manuals, procedure documents, work instructions, and record forms to ensure clients’ system documents comply with regulatory requirements.
- Plan and conduct internal audits and management reviews, and organize responses to third-party audits (such as TÜV, BSI, NMPA on-site inspections) and interested parties audits.
- Provide third-party audit services to clients, conducting on-site audits of factory quality management systems based on standards such as ISO 13485 or GMP,etc., issuing audit reports, and providing improvement recommendations.
- Track updates to quality management regulations for medical devices, pharmaceuticals, and biological products both domestically and internationally, and promptly drive system adjustments.
- Organize training on quality system standards and related regulations to enhance quality awareness and compliance capabilities of the team and clients.
Qualifications
- Bachelor’s degree or above in medicine, pharmacy, bioengineering, mechanical engineering, quality management, or related fields.
- 10+ years of experience in quality management systems within the medical device,or pharmaceutical, or biological product industry, with experience as a system lead, quality manager, or equivalent position.
- Familiar with and able to correctly apply medical device or pharmaceutical regulations and standards from China, the EU, and the US (ISO 13485, GMP, FDA QSR 820, etc.).
- CCAA (China Certification and Accreditation Association) registered auditor certification with practical third-party audit experience.
- Strong leadership and organizational skills, independent decision-making ability, and excellent communication, comprehension, execution, and information processing capabilities.
- Meticulous and responsible work attitude, continuous learning mindset, and willingness 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.