Specialist Quality & Regulatory Affairs - Medical Device Environment (w/m/d)

PAUL HARTMANN AG

Berufsfeld
Gesundheit und medizinische Versorgung

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Specialist Quality & Regulatory Affairs - Medical Device Environment (w/m/d), PAUL HARTMANN AG

At HARTMANN, we're all in to help , care , protect and grow . We support healthcare professionals, that they can focus on what really matters: to positively impact people's life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make.

Join our team as

Manager Regulatory Affairs Operations (w/m/d)

DEU-Heidenheim

Join HARTMANN and become part of a global team that's shaping the future of healthcare . As a Manager Regulatory Affairs Operations (f/m/d) we offer you a varied and challenging position in an international environment in the Division Risk Prevention. 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
You will assume portfolio responsibility for the products under your care
Ensure compliance throughout the product lifecycle
Global monitoring and improvement of regulatory product documentation and conformity assessments
You will be responsible for driving the optimization of the IT infrastructure related to regulatory documentation management
Provide strategic and technical consulting on regulatory issues
Evaluation of product-related regulatory requirements with focus on risk management, labeling and post-market surveillance
Support complaint management

Qualification:

University degree in science or technical sciences or an equivalent qualification
Professional experience in the medical device environment or another regulatory field of work
Proven experience with MDR and ISO 13485
Knowledge and/or experience in the areas of medical devices, technical documentation and regulatory product documentation, conformity assessment and post-market surveillance
Familiarity with FDA regulations and guidelines is desirable
A strong interest in and knowledge of electronic regulatory document control and management systems and associated processes
Open and competent attitude when working with internal partners
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
International 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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