Regulatory Compliance Specialist & Special Tasks Coordinator - Dietzenbach, Germany - DEU 2022-005

Job Title

Regulatory Compliance Specialist & Special Tasks Coordinator

Job Facts

Organizational Area
Country / State
Place of work
Home/Office based
Office based

Professional Family: 

  • Operations
Reporting To
Manager Quality Assurance

Kind of contract

Full Time / Part Time
Full Time
Permanent / 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

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).
  • 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
  • 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)
- Fluent German (spoken and written) - Very good English (written and spoken)
Travel Availability
No as a routine part of the job
Relocation Availability
Training Required

Initial training program


We Offer You

As per local and Company requirements