Address
Form of workPRINCIPAL DUTIES AND RESPONSIBILITIES:
EXPERIENCE AND REQUIRED SKILLS:
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
- Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs.
- Prepare together with Project Manager's the design and development documentation for project and for design control activities.
- Support Product Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier.
- Provide Training on design & development relevant quality requirements.
- Provide input to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Product Center for Design Quality part.
- Review and approve all product development and Design Change projects in compliance with Fresenius Quality Management System / SOP requirements by:
- Preparation / Review and approval of applicable design control documentation-Design Review, Phase Exit Review and Milestone approval
- Preparation of applicable document and sample review of design control documentation during project execution
- Quality Approver for Design and Development related NC/CAPA
- Creation and monitoring of compliance metrics of design controls in development and change management activities.
- Audit support of design and development sessions
- Providing management quality review inputs for Design and development
- MD Compliance Expert: support of Product Center in writing MDR Technical Documentation and related documentation.
EXPERIENCE AND REQUIRED SKILLS:
- Technical/Engineering / Scientific background (degree)
- Experience of minimum 2-3 years in Regulatory Affairs or similar in pharmaceutical/medical field
- High identification with and loyalty to the department, the vertical and the company
- Good and professional relationship to and communication with international colleagues and superiors.
- High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees.
- Organizational capacity and analytical ability
- Independent working structure
- Autonomy in decision making.
- Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)
- Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR, etc.)
- Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
- Knowledge of CAPA methodology
- Knowledge in statistical methods
- Support Regulatory Affairs
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
