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