Lead Regulatory Affairs Specialist (m/f/d)

The Lead Regulatory Affairs Specialist ensures that: medical devices and the steps involved in developing, testing, and marketing them meet all applicable regulatory requirements, and 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. Operational responsibility is an important part of the role.

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 Design Control and Design Change processes:

• Support the development and updating of the design control processes, and of the parallel applicable processes and guidelines
• Subject-specific involvement in the implementation of the risk management process, clinical evaluation, and usability file
• Control and sole responsibility for reviewing/releasing approval-relevant documents as part of the design control process, in particular Risk analysis/risk management, clinical evaluation, design validation/design verification plans and protocols, software documentation, instructions for use and product labeling
• Management of/ responsible for the regulatory evaluation of change orders and checking for approval relevance
• Management of/ responsible for processing RA-related general inquiries

Subject Mater Expert for the interpretation of standard requirements, e.g. for clinical evaluation, biocompatibility, electrical safety, cyber security etc.

Regarding Customer Support and External Contacts:

• Interface between the RA departments of customers, the notified body and authorities
• Support of audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR

Regarding Safety-related incidents:

• Processing of safety-related complaints in cooperation with the Medical Affairs team

General Tasks

• Initiating and monitoring processing of measures to maintain the QMS (e.g. process adaptation)
• 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 (5-8 years) of extensive and well-founded functional professional experience
• Completed studies in the natural sciences, engineering, medical or comparable field
• Advanced training “Manager Regulatory Affairs for Medical Devices”
• Languages: English Level CEFR C1*, German Level CEFR B2*
• Quality-oriented, reliable, and dependable
• Self-motivated
• Team player
• Independent and self-reliant

Excellent communication skills Well-structured and systematic way of working

Travel Requirements

Willingness to travel to different NOVT locations and business partners - Up to 10% traveling time

Physical Requirements

None

Summary