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