Specialist Quality Assurance Operations (f/m/d)

PAUL HARTMANN AG

Berufsfeld
Gesundheit und medizinische Versorgung

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Specialist Quality Assurance Operations (f/m/d), PAUL HARTMANN AG

At HARTMANN you have the opportunity to become part of a global team in the Business Division Risk Prevention. As a Specialist Regulatory Affairs Operations (f/m/d) we offer you a varied and challenging position in an international environment. Here you can develop your skills and play an active role in ensuring product quality and regulatory product conformity. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.

Responsibilities:

In this cross-functional and global role, you will collaborate with teams including R&D, Quality Assurance, Manufacturing, and Marketing to ensure the implementation of products on time according to regulatory requirements
Ensure compliance throughout the product lifecycle
Global monitoring and improvement of regulatory product documentation and conformity assessments
Contribute to optimizing the IT infrastructure for the management of regulatory product documentation
Provide strategic and technical consulting on regulatory issues
Evaluation of product-related regulatory requirements with focus on risk management, labeling and post-market surveillance

Qualification:

University degree in science or technical sciences or an equivalent qualification
Ideally initial professional experience in the medical device environment or another regulatory field is a plus
Knowledge and/or experience in the areas of medical devices, technical documentation and regulatory product documentation, conformity assessment and post-market surveillance and risk management
Familiarity with FDA regulations and guidelines is desirable
Ideally a strong interest in and knowledge of electronic regulatory document control and management systems and associated processes
Strong communication skills with an open and professional attitude when collaborating with both internal and external partners
IT affinity and proficiency with the MS Office package
Fluent written and spoken German and English

Benefits

Flexible working conditions, such as flexible working hours and mobile working
Attractive ways of combining work and family life, e.g. childcare subsidy
30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
Company pension plan with attractive employer contribution incl. matching model for deferred compensation
Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
Job Bike Leasing
Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform

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