Sr Regulatory Affairs Operations Manager - Medical Device

Your area of responsibility:

• You will act as a RAO Business Partner, working closely with Marketing and Development to manage development projects and changes from a RA perspective
• Coordination of the internal RA functions and support in the transfer projects in order to jointly make the technical documentation MDR capable
• Global supervision and enhancement of regulatory product documentation, conformity assessment and resulting Declaration of Conformity based on global regulatory compliance
• Strategical and conceptional development of Regulatory Affairs Operations Department
• Support of by strategically and technical advice in regulatory issues
• Strategical planning, conceptional development and performance of trainings and mentoring in regulatory issues and needs with regards to the defined area of responsibility global regulatory product documentation and conformity assessment

What we look for:

• Masters degree in life-, natural- or technical-sciences or equivalent education
• 5+ years experience within the field of health care industry
• Knowledge of/experience in active and non-active medical devices, Technical Documentation, regulatory product documentation, conformity assessments and post-market surveillance
• Strong knowledge of and experience in global regulatory requirements for medical devices, and personal protective equipment with regards to marketability
• Ideally knowledge and experience in European and Germany regulatory requirements for drugs, biozid products and chemicals
• Knowledge of business processes and global quality management systems in medical device industry e.g. ISO 13485, 21 CHR 820 and more
• Fluent in English both oral and in writing – German basic knowledge is a MUST

Benefits:

• Stable and continuously growing company with over 200 years of company history
• A motivated and helpful team, which is fully behind our meaningful products
• Reconciling work and family life
• Flexible working hours and attractive remuneration
• Occupational pension provision
• Comprehensive health management with massage and sports facilities
• Individual training
• Extended infrastructure (parking lot, canteen etc.)