Specialist Regulatory Affairs Operations (f/m/d)

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

• 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

• 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