Product Center Manager PD fluids

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

About Us

Creating a future worth living. For patients. Worldwide. Every day.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables.

We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.