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
Specialist Regulatory Affairs Operations (f / m / d)
DEU-Heidenheim
At HARTMANN you have the opportunity to become part of a global team. 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 qualificationIdeally initial professional experience in the medical device environment or another regulatory field is a plusKnowledge and / or experience in the areas of medical devices, technical documentation and regulatory product documentation, conformity assessment and post-market surveillance and risk managementFamiliarity with FDA regulations and guidelines is desirableIdeally a strong interest in and knowledge of electronic regulatory document control and management systems and associated processesStrong communication skills with an open and professional attitude when collaborating with both internal and external partnersIT affinity and proficiency with the MS Office packageFluent written and spoken German and EnglishBenefits
Flexible working conditions, such as flexible working hours and mobile workingAttractive ways of combining work and family life, e.g. childcare subsidy30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreementCompany pension plan with attractive employer contribution incl. matching model for deferred compensationPlenty of parking spaces, canteen with café bar and ongoing offers in the employee shopAccess 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 LeasingAttractive discounts on e.g. travel, fashion and technology via our corporate benefits platformShape a career that’s focused on healthcare customers, fit for the future and grounded in a culture of trust and openness. Apply now via our online platform.
Your personal contact :
Isabel Proske
the male form is for simplification only and stands for the gender-neutral description of the profession