Manager Regulatory Affairs (m/f/d)

Overview

• 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.
• 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
• 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
• Management of safety-related complaints in cooperation with the Medical Affairs team
• 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
• 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 agencie

Starten Sie eine Karriere mit Innovationen, die den Unterschied machen! Novanta  treibt mit seinen Innovationen Technologien voran, die das Gesundheitswesen und die moderne Fertigung verändern, die Produktivität steigern, die Lebensqualität der Menschen verbessern und das Machbare neu definieren. Für unsere Kunden weltweit entwickeln wir technische Komponenten und Subsysteme, die extreme Präzision und Leistung für eine Reihe von unternehmenskritischen Anwendungen bieten – von der minimalinvasiven Chirurgie über die Robotik bis hin zum 3D-Metalldruck.

Novanta ist ein globales Unternehmen mit über 26 Standorten in Nord- und Südamerika, Europa und im asiatisch-pazifischen Raum. Sie suchen einen tollen Arbeitgeber? Sie haben ihn gefunden – mit einer Kultur, in der Teamwork, Zusammenarbeit und Empowerment eine wichtige Rolle spielen. Lernen Sie Novanta kennen.

Business Unit Overview

This position is part of Novanta’s Advanced Surgery business unit . Specialized in the field of Minimally Invasive Medicine, Advanced Surgery develops devices and accessories so that doctors can operate with small cuts. We produce eg Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate.

Position Details

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:

Primary Responsibilities

Regarding Regulatory approval of medical devices:

Regarding Customer Support and External Contacts:

Regarding Safety-related incidents:

General Tasks

Required Experience, Education, Skills, Training and Competencies