Responsibilities
1) Main tasks:
• Fulfill PCM role as described in QMS
• Main contact for compliance (regulatory/quality/product safety) of concerned products
• Evaluation of regulatory requirements for new developments and changes to existing products
• • Identification of opportunities for local market access
• Definition of product risk class (for devices as applicable)
• Responsible for regulatory and quality compliance of related products throughout their lifecycle
• Risk management responsible throughout the complete product life cycle
• Assessing potential product risks (from market observation and quality problems)
• Regulatory evaluation of design changes
• Initiating and supporting CAPA measures (product safety and regulatory changes, risk evaluation)
• Supporting post market surveillance/pharmacovigilance process
• Support / review DHF/DMR/BMR activities as applicable
2) Secondary tasks:
•Tasks performed regularly in addition to the main duties, but which do not determine the essential character of the position.
• Initiating, supporting and releasing design changes
• Support selection of regulatory pathway/product classification
• Support domestic registration
• Providing support during creation and maintenance of the clinical evaluation
• Support for clinical or post-market studies
• Support development projects as CFT member with compliance expertise
• Support during internal/external audits regarding design changes and regulatory product files
• Support product quality and compliance monitoring
• Support processing of regulatory actions (e.g., FSCA, recall)
• In the role of the risk manager:
• Responsible for the planning and implementation of risk management, the creation and updating of the risk analysis for concerned products
• Support risk management activities for development projects
• Ensuring that all activities relating to risk management are carried out in accordance with the risk management plan (as applicable)
• Responsible for the risk management transfer into production
• Planning and monitoring risk assessments and transferring relevant contents into the risk analysis
• Responsible for the reconciliation of risk analysis
• Offering support for the creation of FMEAs and anomaly reports
• Comparing the risk analysis with the usability file (as applicable)
• Creating a releasable risk analysis following the corporate process
• Creating the Overall Risk Evaluation Sheet (as applicable)
• Creatin the risk management file or updating an existing RM file
3) Miscellaneous tasks:
•Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work.
• Support global initiatives with regulatory expertise to enable global development and registration.
Qualifications, experience, know-how and skills critical for success*
1) Required training and education:
University degree in Engineering or Science (Graduate, Bachelor, Master) or equivalent education (to be demonstrated)
2) Required professional experience (in years):
• Min. 2-3 years of work experience in research and development, in quality management, or in the registration of medical devices or medicinal products in China
3) Important personal qualities:
• Problem solving
• Decision quality
• Action oriented
• Dealing with ambiguity
• Managerial courage
• Interpersonal savvy
4) Other specialized knowledge:
a) Technical knowledge
• Good knowledge of research and development, quality management, or regulatory affairs environment for medical devices and medicinal products
• Good knowledge of the regulatory environment of medical devices or medicinal products in China
• Knowledgeable in international standards/regulations (e.g., ICH, ISO, GMP)
• Good knowledge of risk management for medical devices/medicinal products
• Basic knowledge in project management
b) Languages
• Profound knowledge of the Chinese language
• Very good English skills
c) IT skills
• Good knowledge of MS Office 365 (e.g., Outlook, Excel, Word, PowerPoint)
d) Product knowledge
• Good knowledge in the field of dialysis (e.g., PD and CRRT) advantageous
5) Special personal requirements:
• Irregular, short business trips, including internationally
• Willingness to have flexible work hours
