Job Title
Job Facts
Professional Family:
- R&D - SD&I
Kind of contract
Job Scope
To act as the Team’s primary interface to the Quality and Regulatory departments within the Company, for all what relates to the documental side of development and improvement of the Immuno devices, with particular reference to complex and multi-faceted systems and projects.
Main Responsibilities
- Build and keep updated development documents with primary quality relevance, such as Risk Management Plan, Risk Analysis, Gap Analysis, Impact Analysis, for complex projects involving a broad spectrum of competences
- Manage Change Plans and Change Requests within the QMS, in particular:
o Issue of the Change Plan / Change Request
o Preparation of the related deliverable and task plan
o Negotiation and fine tuning of the CP/CR and related deliverables
o Monitoring of advancement for tasks and related formal approvals
· Supervision to regulatory requirements related to or impacting on systems for specific markets
· Guidance for submissions and consultations to notified bodies and agencies (e.g. USA FDA, China NMPA)
· Preparation of answers to enquiries from notified bodies and agencies
· Issue and update of procedures relevant for the Team
· Issue and update end certain documents for end users, where the quality / regulatory impact is relevant
· Direct cooperation with the technical teams for the preparation of the mentioned deliverables
· Direct cooperation with QA/RA teams
Qualifications Experience Personal Strengths Mobility
3-5 years’ experience in an equivalent role or as a QA/RA specialist
· 1-2 years’ experience in a technical field is a plus
· Previous experience in IVD (In Vitro Diagnostics) and/or highly regulated FDA environments and biotechnology industry experience is highly appreciated
· Knowledge of GMP (Good Manufacturing Practice) is appreciated
· Experience with working under ISO 13485
· Used to discuss technical topics
· Seasoned experience using Microsoft Office package
· Effective ability to analyze and synthesize
· Interdisciplinary thought
· Clear and concise writing skills
· Well organized, ability to work well independently as well as part of a team
· High commitment and willingness to learn
· Positive, proactive and open-minded attitude
· Focus on results
Induction program once hired
Benefits
As per Company Policy