Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Geislingen an der Steige, Baden-Württemberg - HARTMANN
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Regulatory Affairs Specialist
vor 2 Monaten
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at HARTMANN. As a key member of our global team, you will play a critical role in ensuring product quality and regulatory product conformity.
Responsibilities- Ensure timely labelling and implementation of products according to regulatory requirements
- Monitor and improve global regulatory product documentation and conformity assessments
- Responsible for master files of package inserts, labels, and artwork, checking for correctness and necessary labeling requirements in the review and approval process
- Develop proposals to improve IT infrastructure for regulatory product documentation management
- Provide strategic and technical consulting on regulatory issues
- Final evaluation of product-related regulatory requirements
- University degree in science or technical sciences or equivalent qualification
- Initial professional experience in the medical device environment or another regulatory field of work
- Knowledge and/or experience in medical devices, technical documentation, and regulatory product documentation, conformity assessment, and post-market surveillance
- 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
- IT affinity and proficiency with the MS Office package
- Strong communication skills, persuasiveness, and assertiveness
- Fluent written and spoken German and English
- Flexible working conditions, including flexible working hours and mobile working
- International mobile working
- Attractive ways of combining work and family life, e.g. childcare subsidy
- Days paid leave per year, plus special leave for exceptional life events, vacation pay, and special annual payment according to collective agreement
- Company pension plan with attractive employer contribution, including 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, Crossfit, and bouldering halls (EGYM Wellpass)
- Variety of 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
