TOMTEC IMAGING SYSTEMS GMBH, with headquarter located in Munich / Germany, is a worldwide leader for medical image software solutions. Specialized in cardiology it offers state-of-the-art solutions for clinical customers and industry partners.
The products encompass a wide range of 2D and 3D/4D technology for visualization, automated analysis, quantification, reporting and image management. TOMTEC products are available for adult and pediatric cardiology, obstetrics, gynecology, radiology and vascular diagnostics. Moreover, TOMTEC offers a sustainable full-service component in sales and an education program with best-practice sharing among professionals.
The company claim "Excellence in Digital Healthcare" represents striving for excellent image and analysis quality, ease-of-use, reproducibility of automated measurements and an all-around service- and education offering. The company maintains close working relationships with many leading universities and research institutes around the world.
In July 2017, TOMTEC became a part of the Philips Ultrasound Business group. However, TOMTEC is continuing its vendor independent product portfolio.
In this role, you have the opportunity to
Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission.
You will manage a team of 2 regulatory subject matter experts supporting various new and sustaining programs and will work closely with the regulatory team members, most of which are located in the US territory. Additionally you will be responsible for providing direct support to business critical New Product Introduction projects and maintaining the lifecycle of regulatory processes that are relevant to meet state of the art requirements.
You are responsible for
Leading the team of regulatory professionals responsible for establishing and executing innovative regulatory strategies;
Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained;
Reviewing and recommending changes for design control processes and manufacturing procedures to maintain quality and regulatory compliance;
Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally;
Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements are determined to go into effect;
Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols;
Advising on regulatory policy (for market release) in line with TOMTEC and Philips regulatory policy;
Where applicable, represent TOMTEC in an international committee chartered to develop an applicable standard as well as in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body;
You are a part of
You are a part of the local TOMTEC team in Unterschleißheim and the Philips Ultrasound Regulatory Affairs Organization with a global footprint. You will report to the Head of Regulatory Affairs for Business Group Philips Ultrasound. The Regulatory Affairs team is multicultural and consists of enthusiastic professionals that work as a team to ensure regulatory compliance.
To succeed in this role, you should have the following skills and experience
Bachelor/Master of Science degree in a technical or business discipline;
Minimum of 8 years of relevant experiences
Management experience is preferred;
First line experience with US FDA and EU MDD, , China NMPA preferred;
Understands the requirements surrounding EU MDR requirements;
Maintains detailed knowledge on the subject of ISO 13485 and QSR requirements;
Experiences surrounding international regulatory submissions and registrations;
Experience with successful preparation and submission of Technical Documentation, 510(k), PMA, and registrations of medical devices globally;
Experience with Software as Medical Devices, Ultrasound Imaging Devices is preferred;
Team player who can work in a matrixed environment with teams in different locations;
5-10% of travel may be required;
In return, we offer
Working in a motivated team
Versatile, challenging tasks in a growing company in an international environment
An innovative environment with the chance to evolve
An excellent working atmosphere with flat hierarchies and short decision makings
An attractive and dynamic- salary package, excellent employee benefits and supplementary pension
Flexible trust-based working hours, massages, sports courses, regular team events and much more
Please apply online via our website with your full application.