Head of Regulatory Affairs Risk Prevention (f/m/d)

at  Hartmann

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

QUALIFICATION:

• A University degree in life science, natural science or an equivalent qualification
• At least 5 years of relevant professional experience in a Regulatory Affairs role within an international company
• Qualification as PRRC according to MDR
• Comprehensive knowledge of the regulatory requirements of medical device (e.g. MDR, MDD, MPG/MPDG/MPSV, MEDDEV, EN ISO 13485, 21 CFR 820), as well as personal protective equipment and In-vitro diagnostics related to product safety and risk management
• Proven experience in leading and developing a team
• Strong project management skills, with a preference for experience in managing international projects
• Excellent communication and collaboration skills, with experience working effectively with cross-functional stakeholders at all levels, including in a matrix organization
• Fluent written and spoken English and German

• Responsible for ensuring compliance with all regulatory requirements of the entire product portfolio in all relevant markets of the division, including the monitoring of specified standards and legal requirement
• Support the business division in the development and implementation of regulatory strategies within the framework of projects and strategic initiatives
• Lead the divisional Regulatory Affairs department, comprising a team of six members
• Evaluate and define the proper regulatory strategy approach for each product
• Manage, coordinate and contribute to the post-market surveillance, labeling, regulatory product documentation, conformity assessments for the respective business division
• Contribute in the writing and reviewing of Regulatory processes. Ensure that resources and activities are aligned with the commercial objectives.
• Contribute to the clinical, biological, risk management, usability, standards & regulations management, for the respective business divisio