Vigilance & Complaint Manager (m / f / d) at the Berlin / Jena / Oberkochen locations

GULP – experts united; Oberkochen; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leader in medical technology recruitment is seeking a Vigilance & Complaint Manager to handle critical compliance and quality management processes. The ideal candidate will possess a completed university degree in a technical field and have professional experience in vigilance or post-market surveillance. Fluency in English and knowledge of medical device regulations are essential. This role is based in Germany with a competitive salary and extensive benefits.

Leistungen

Attractive salary

Up to 30 days vacation

Company pension scheme

Social benefits

Travel expense reimbursement

Language courses

Employee benefits

Qualifikationen

• Professional experience in quality management in vigilance or post-market surveillance.
• Fluency in written and spoken English; knowledge of another foreign language is a plus.
• Sound knowledge of medical device standards, especially ISO 13485 : 2016.

Aufgaben

• Perform statistical analyses and prepare trend reports.
• Manage (cross-functional) sub-projects.
• Ensure compliance with reporting deadlines and local/global requirements.

Kenntnisse

Quality management

Regulatory knowledge

Analytical skills

Communication

Independent working

Ausbildung

Completed university degree in a technical or scientific field

Tools

Power BI

Jobbeschreibung

For our client, a company in the precision engineering industry (medical technology), we are looking for someone with your expertise in the position of Vigilance & Complaint Manager (m / f / d) at the locations Berlin / Jena or Oberkochen with the following focus :

Here's what we offer

• Attractive salary and long-term job security through group affiliation
• Up to 30 days vacation per year
• Contribution to company pension scheme after end of probationary period
• Extensive social benefits, including Christmas and vacation bonuses
• Reimbursement of travel expenses
• As a rule, a permanent employment contract
• Good chances of being taken on by our business partners
• Tailored further training opportunities and free language courses
• A wide range of employee benefits
• Recording complaints, assessing criticality and ensuring compliance with reporting deadlines in accordance with local and global requirements (e.g. EU MDR, FDA 21 CFR)
• Initiating root cause analyses and coordinating with specialist departments to define and initiate countermeasures to improve product quality
• Process-compliant processing of safety corrective measures in the field
• Timely reporting of vigilance activities and communication with global authorities
• Performing statistical analyses and preparing trend reports for health authorities and internal processes
• Planning and management of (cross-functional) sub-projects
• Contributing to the maintenance of the QM system according to ISO 13485 : 2016 and the development, standardization and continuous improvement of vigilance and complaint management processes
• Collaborating with other departments and contributing to overarching processes, e.g. post-market surveillance

Your profile

• Completed university degree, preferably in a technical or scientific field (e.g. medical technology, pharmaceutical technology, optometry) or equivalent professional experience in combination with a relevant degree.
• Professional experience in the development and further development of quality management and quality improvement measures in the area of vigilance or post market surveillance, ideally in the field of medical technology.
• Fluency in written and spoken English is required; ideally you will have knowledge of another foreign language.
• Sound knowledge of medical device standards, especially in quality management, such as ISO 13485 : 2016, as well as relevant laws and regulations, including MDR 2017 / 745, 21 CFR 820, 803 and 806
• Experience in analyzing regulatory requirements and using databases
• Basic knowledge of statistics and database analysis is an advantage
• Knowledge of creating dashboards with Power BI is desirable
• An independent, structured and sustainable way of working rounds off your profile