Job Title
Regulatory Compliance Specialist & Special Tasks Coordinator
Job Facts
Legal Entity
Organizational Area
DACH
Country / State
Germany
Place of work
Dietzenbach
Home/Office based
Office based
Professional Family:
- Operations
Reporting To
Manager Quality Assurance
Kind of contract
Full Time / Part Time
Full Time
Permanent / Temporary
Temporary
Job ID
DEU 2022-005
Job Scope
Your Mission
Ensure "Regulatory Compliance"
Coordinate special tasks with regard to maintaining the QM system for the worldwide approval and registration of DSD products in compliance with applicable legal and normative requirements
Perform QA approval tasks
Ensure GMP compliance and quality management requirements in the responsible area.
Main Responsibilities
Your Contributions
- Ensure regulatory compliance by monitoring legal and normative product-specific requirements (IVDR, MPDG, standards)
- Manage projects related to "Regulatory Compliance" (updating of standards revisions, updating of European directives)
- Responsible coordinator of standards management (distribution of standards to departments, support of departments in the implementation of requirements in the QMS)
- KPI provision for the area "Complaints" as a stand-in for the QA Manager
- Collaborate in the risk management team as "Subject Matter Expert”
- Collaborate in the Vigilance Team and the PRRC
- Execute QA approval tasks according to delegation (CoC approvals, supplier evaluation etc.)
- Execute internal audits in other divisions
- Collaborate in internal and interdepartmental projects
- Ensure GMP conformity and quality management in the responsible area
- Special tasks on special instruction on a case by case basis
- Further/other tasks which are reasonable within the scope of the qualification
Qualifications Experience Personal Strengths Mobility
You
Education
Completed scientific or engineering education preferably in the field of biochemistry, biology, chemistry, process engineering, or similar (e.g. Bachelor, Diploma, Master or equivalent technical education).
Specialization
-
Experience
- Several years of experience in quality assurance of an in-vitro diagnostics (IVD) company in the medical industry.
- Experience in writing QM documents (according to ISO 13485, GMP, GLP, 21CFR820, or similar)
Technical Competencies
- Good technical understanding
- Basic immunological knowledge
- Knowledge of immunoassays as well as database experience
- Good knowledge of MS Office (especially Excel and Word) and profound knowledge of Lotus Notes
Skills
- Ability to self-organize, prioritize and work in a structured manner
- Organizational and conceptual thinking skills
- High degree of diligence and reliability
- High level of social competence (good communication skills, active listening, openness, cooperative working style and strong teamwork skills)
Languages
- Fluent German (spoken and written) - Very good English (written and spoken)
Travel Availability
No as a routine part of the job
Relocation Availability
No
Training Required
Initial training program
Benefits
We Offer You
As per local and Company requirements