Regulatory Affairs Manager for Post-Market Surveillance (f/m/d)

At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (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 the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.

Responsibilities:

• Provide and update documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance
• Cross-functional communication with other departments such as Marketing and R&D to ensure required input documentation is up to date
• Coordinate external service providers to support clinical evaluation documentation, PMCF and PMS
• Determine clinical evidence requirements according to MDR and relevant MDCGs
• Identify equivalence to existing devices, if required, in accordance with MDRs and relevant MDCGs.
• Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
• Provide searches in relevant vigilance databases
• Support for risk analysis and study planning for CE and PMCF studies

• University degree in life science/natural science or an equivalent qualification
• Professional experience in the medical device environment or another regulatory field of work
• Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs
• Experience in literature search and review required as well as knowledge of regulatory medical writing
• Knowledge of database management
• Open and competent attitude when working with your stakeholders
• IT affinity and proficiency with the MS Office package
• Fluent written and spoken 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