In this role, you oversee regulatory affairs by managing teams, optimizing processes, and ensuring compliance with safety and quality standards. You also handle documentation and support audits, which contributes to the overall effectiveness of the organization.
Anforderungen
- •Long-term experience (8-12 years)
- •Manager experience preferred
- •Knowledge and creativity
- •Completed studies in natural sciences or engineering
- •Expertise in regulatory affairs
- •Advanced training in Regulatory Affairs
- •English C1 and German B2 proficiency
- •Independent and quality-oriented
- •Self-motivated
- •Team player
- •Effective communication with stakeholders
- •Well-structured and systematic working
- •Willingness to travel up to 10%
Deine Aufgaben
- •Manage technical and disciplinary aspects of teams.
- •Design and optimize structures and processes.
- •Assign and schedule employees based on skills.
- •Conduct regular employee performance appraisals.
- •Plan resources and budgets for teams.
- •Ensure occupational safety and environmental protection.
- •Compile approval-relevant documents and certificates.
- •Prepare documentation for evaluations by authorities.
- •Control technical documentation for conformity assessments.
- •Act as an interface between regulatory departments.
- •Support audits with customers and authorities.
- •Manage safety-related complaints with Medical Affairs.
- •Initiate and manage quality management system processes.
- •Drive innovation processes within the department.
- •Ensure compliance with quality and safety regulations.
- •Implement instructions from quality and safety representatives.
Original Beschreibung
# Manager Regulatory Affairs (m/f/d)
**Berlin, Germany** | **Full time**
**Summary**
The Manager Regulatory Affairs is responsible for regulatory submissions and approvals for initial placing and maintaining the devices on the market are timely performed.
To make this happen the employee anticipates and plans appropriate tasks and coordinates relevant cross-functional teams.
Your expertise will support successful product launches and compliance throughout the product lifecycle.
**Management Responsibilities:**
* Technical and disciplinary management of the subordinate areas and employees.
* Designing, developing and optimizing the structure and processes of the subordinate areas.
* Assignment, development and scheduling of employees according to requirements and skills
* Conducting regular employee appraisals
* Carrying out and implementing resource and budget planning for the subordinate areas.
* With regard to occupational safety and environmental protection, the prevention of occupational accidents and environmental damage, occupational diseases and work-related health hazards, the manager is entrusted with the responsibility for creating and maintaining facilities for his area and for issuing instructions and taking other measures to ensure, maintain and improve occupational safety and environmental protection.
**Primary Responsibilities**
*Regarding Regulatory approval of medical devices:*
* Management of or responsibility for the compilation of approval-relevant documents including free sales certificates, legalizations, other declarations, and certificates
* Management of or responsibility for compiling documents for documentation evaluations by notified bodies and competent authorities worldwide
* Management of or responsibility for the control/acceptance of technical documentation as part of the conformity assessment procedure, assessment of compliance with the essential requirements, preparation, and release of declarations of conformity
*Regarding Customer Support and External Contacts:*
* Interface between the RA departments of customers, the notified body and authorities
* Support for audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR
*Regarding Safety-related incidents:*
* Management of safety-related complaints in cooperation with the Medical Affairs team
**General Tasks**
* Initiation and management of the processing of measures to maintain the QMS (e.g. process adaptation)
* Initiation of innovation process
* Strict compliance with the quality, occupational safety and environmental regulations
* Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist
**Required Experience, Education, Skills, Training and Competencies**
* Long-term (8-12 years) of extensive and well-founded functional professional experience
* Experience as manager preferred
* Knowledge, creativity, ability and willingness to take responsibility to put multiple and sometimes contradictory inputs into context
* Completed studies in the natural sciences, engineering, medical or comparable field
* Possess extensive expertise in regulatory affairs, with a specialized background in the medical device industry
* Advanced training “Manager Regulatory Affairs for Medical Devices”
* Languages: English Level CEFR C1\*, German Level CEFR B2\*
* Independent, Quality-oriented, reliable, and dependable
* Self-motivated
* Team player
* Be able to effectively communicate with internal stakeholders, regulatory agencies, and external partners
* Well-structured and systematic way of working
**Travel Requirements**
* Willingness to travel to different NOVT locations and business partners - Up to 10% traveling time
# LI-UK1
# Berlin