Medical Devices | Software RA Consultant, Badenweiler

Discipline Medical
Job reference 9035
Salary Competitive
Consultant name Kieran Phillips
Consultant email kieran@projectusconsulting.com
Badenweiler (3/4 days onsite)

Working for a small consultancy full-time - helping start-up businesses with RA for medical device software in Germany predominantly 

Requirements 
  • MUST speak German: fluent
  • >3 years in SW IEC 62304 experience
  • Rather Software testing for 62304, preferably experience in Design as well
  • Any medical software
  • able to commute for first 6 months 3 days in the office
It is only RA for software but the person should have sufficient expertise in testing and preferably also design.

First 6-12 months are at least 3-4 days onsite to establish a team relationship. The 6-12 onboarding time might be shorter if the person is very experienced already
e.g. 8y+ experience in RA SWE consulting

Who are we?
CE plus GmbH specializes in international regulatory affairs for medical devices and in vitro diag-nostics. The spirit of partnership is important to us - not only in our relationships with our clients and partners but also in the relationships among the individuals who work for CEplus. Our business culture is based on open communication and on a structure that accommodates each individual's knowledge and skills. As an ambitious and progressive independent Regulatory Affairs service provider, we offer the opportunity for a Regulatory Affairs Expert in Software as a Medical Device to join our team based in Southern Germany near Basel (Badenweiler).

What we offer:
As a Regulatory Affairs Expert on medical devices you will focus on the regulatory support of medical device / IVD software throughout the entire product lifecycle. You will also have the opportunity to work on a variety of different projects within our CEplus team and you will be involved in various tasks, such as:
• Compilation of Technical Documentations
• Ensure fulfillment of EU requirements (93/42/EEC, 98/79/EC, 90/385/EEC) as well as new EU regulations 2017/745 und 2017/746
• Interactive collaboration with In-house experts covering all subjects related to CE-marking of medical devices /IVDs (preclinicians, clinicians, QM etc.) Implement and maintain regulatory SOP’s within ISO 13485
• Close interaction with international clients as well as Notified Bodies and Competent Authorities
• Development of creative solutions in order to fulfill client needs combined with regulatory requirements
Skills/Qualifications:
• A background in software engineering
• Experience with key topics of a software development lifecycle, such as software requirement analysis, software architecture, detailed software design, testing (Modul, Integration, System), maintenance
• Excellent project management skills
• Good written and oral communication skills in German and English
• Being a team player is a must
Preferable but not mandatory:
• Practical experience in CE-marking of software
• Ensuring or implementing fulfillment of IEC 62304
• Experience with international registrations such as 510(k)
• Knowledge in IEC 60601-x and closely related standards, such as ISO 14971 or IEC 62366
• Experience in medical device or IVD industry, preferably in regulatory affairs and/or quality management related positions; Notified Body experience