Dqa & Md Compliance Expert (M/F/D) Bardi

Dqa & Md Compliance Expert (M/F/D)
Bardi
Emilia Romagna, Bardi

In your role as DQA & MD Compliance Expert (M/F/d) you will be responsible for assure the quality of design control activities and correctly realizing product development processes and maintenance of product compliance.

**Your assignments**:

- 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 of DHF 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

- 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.

**Your profile**:

- Technical / Scientific background (degree)

- Experience of 2-3 years in Regulatory Affairs or Quality environment in pharmaceutical/medical field

- Experience in R&D

- 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

- Autonomy in decision making

- Good knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc. )

and of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR -820. 250, etc.

)

- Knowledge of CAPA methodology and statistical methods

- Experience in project management will be a plus

- IT user skills in MS Office (TrackWise Workflow or Windchill PDM systems are an advantage)

- Fluent in English (written and spoken)

**Our offer to you**:

We offer permanent contract, the remuneration will be commensurate with the experience