Manager Regulatory Affairs (f/m/d)

- Full-time - Permanent - Mobile working partly possible -

As Manager Regulatory Affairs you will be responsible for the strategic and operational planning and implementation of regulatory requirements in the area of active and non-active medical devices (class I - IIb). A particular focus of your work will be the creation and maintenance of technical documentation in accordance with the Medical Device Regulation (MDR) and international standards. You will act as an interface between internal teams (product development, quality management, marketing) and external authorities to ensure market approvals and continuous compliance.

Main tasks and responsibilities

1. develop and implement regulatory strategies:

• Develop regulatory strategies for medical devices, especially with regard to MDR, FDA and other international regulations.
• Ensure global compliance and adaptation to country-specific requirements.

2. technical documentation (focus):

• Creation, maintenance and updating of technical documentation in accordance with MDR (EU 2017/745), including:
  - Risk management files (according to ISO 14971)
  - Clinical evaluation and post-market clinical follow-up (PMCF)
  - Instructions for use and labeling
  - Performance data and test reports
• Coordination of the preparation and submission of documentation to Notified Bodies and competent authorities.
• Ensuring that the technical documentation is ready for audit at all times.

3. internal consulting and training in the field of medical devices:

• Supporting product development in MDR-compliant planning and implementation of medical devices.
• Conducting internal training courses on regulatory requirements, with a particular focus on the requirements for technical documentation.

4. risk assessments for medical devices:

• Evaluation of regulatory risks with regard to technical documentation and product conformity.
• Development and implementation of risk mitigation measures in close cooperation with quality management and development teams.

5. market surveillance and MDR compliance :

• Planning and implementation of Post-Market Surveillance (PMS) and PMCF activities for approved medical devices.
• Monitoring and implementation of changes in MDR and relevant regulatory requirements.

Requirements

• Degree in science, engineering, pharmacy, medical technology or a related field.
• At least 5 years of experience in regulatory affairs, preferably in the medical device sector for active devices.
• Profound knowledge in the approval and lifecycle management of medical devices according to MDR and international standards (esp. IEC 60601 series).
• Expertise in regulatory requirements of MDR (EU Regulation 2017/745) and FDA regulations (21 CFR 820).
• Practical experience with technical documentation and clinical evaluations for medical devices
• Familiarity with quality management systems according to ISO 13485.
  

Skills:

• Strong analytical and problem solving skills in a regulatory environment.
• Excellent written and verbal communication skills (German and English).
• Experience in project management and working with interdisciplinary teams.
• Initiative and a proactive approach to regulatory challenges.
• Ability to interpret and clearly communicate complex regulatory requirements
• Ability to work in a team in a multidisciplinary and international environment.
• High level of accuracy and attention to detail.