Post Market Quality and Regulatory Professional - Bonn, Deutschland - Dedalus SA

Dedalus SA

Geprüftes Unternehmen

Bonn, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Vous souhaitez donner du sens à votre métier ?
Vous voulez contribuer à l'amélioration de nos soins de santé ?
Alors rejoignez notre équipe

Dedalus Group is the leading healthcare and diagnostic software provider in Europe and one of the largest in the world.

With its innovative framework of comprehensive and process-oriented solutions, Dedalus Group enables a revolutionary Digital Transformation of country-wide Healthcare Systems cantered around the patient.

For our offices in Bonn (Germany), Vienna (Austria) or Home based we are looking for a

Post Market Quality and Regulatory Professional (M/F/d)

The earliest entry date for this position is June 2023

As Quality and Regulatory Professional and member of an international team you will ensure quality, regulatory compliance, and safety and efficacy of our medical devices and non-medical products.

Your Challenge:

Embedded in the global Quality and Regulatory Team, you ensure regulatory compliance of our post market activities, managing our Health IT software medical devices.
As key member of our international Product Quality Management Teams you safeguard the resolution of customer complaints escalated for our medical devices and other business critical products.
You drive and guide the cross functional teams addressing product issues and defining and implementing effective preventive and corrective actions.
You drive and ensure compliant and timely resolution of vigilance related tasks like incident and trend reporting, reportable corrections and recalls for all applicable regulatory agencies.
You coordinate and conduct Post Market Surveillance activities and prepare and approve formal written reports, expressing opinions on the adequacy and effectiveness of the system and activity reviewed.
You ensure that customer and service communication is regulatory compliant and accurate Your regular trend analysis reporting on product quality in our customer base supports senior management in taking effective decision for quality improvements.
In our fastgrowing business segment, your regulatory consulting is key in continuous improvement of our business processes.

Your Profile:

University Degree (Engineering, Computer Science or Science) or equivalent from experience
Minimum 3 years' experience in a regulated industry preferably medical device or related in project management, analyst, technical support, quality management, or quality assurance and regulatory affairs position
Familiar with international regulations and standards pertaining to medical devices development and servicing; familiarity with ISO 9001, ISO 13485, ISO 14971, MDR and ability to interpret and work with regulations and standards
Exposure to risk management processes, CAPA, Vigilance Management, Post Market Surveillance and software development
Team player with excellent interpersonal, collaboration, negotiation, conflict resolution, relationshipbuilding, and communication skills
Selfstarter attitude, strong organizational skills, and the ability to meet deadlines
Knowledge of data analysis and statistical techniques, knowledge of R programming language is an asset.
Very good English verbal and written language skills, German, French or Italian is an asset
This position offers stepwise growth, so senior, professionals and junior profiles are welcome

Our benefits for you:

A major challenge in an exciting, innovative and international hightech company
A permanent employment contract for longterm perspective
A competitive salary package complemented by fringe benefits
Flexible working time, adapting to the personal needs and preferences

If you want to be part of our world and future, we'll take you there.
teamdedalus #together4success #dedalusgroup

Dedalus HealthCare GmbH
Human Resources
Konrad-Zuse-Platz 1-3
53227 Bonn