Responsibilities

• provide regulatory support in the field of medical device software according to the clients’ needs. This includes tasks, such as
  • establish software lifecycle process in compliance with IEC 62304 and other relevant regulatory guidelines and requirements
  • assist in planning, performing, and documenting, software validation activities
  • compile technical documentation for medical devices or combination products containing software, or stand-alone software as a medical device (i.e. SaMD)
  • provide expert opinion on the regulation of medical device software in various markets (EU, US, ASEAN, etc.)
• take over the role as project leader securing smooth project progress and comprising key account responsibilities
• be the primary contact for the client
• be engaged in mandate acquisition
• give presentations in the individual specialized field of expertise for clients, at conferences or in external or internal workshops
• contribute content to marketing activities in alignment with function responsible for such activities within confinis

Our Offer

confinis offers the possibility to work self-contained as subject matter expert with a wide variety of clients in the medical device, pharma, biotechnology and diagnostics industry. At the same time, you will be part of a highly motivated and experienced team, which functions as an interlinked support and feedback structure, which you will become a valued part of. Since confinis is providing cutting edge consulting services we will ensure you stay at the forefront of regulatory and quality management challenges regarding medical device software. Take advantage of our competitive compensation package, flexible work scheme and location.
We are looking forward receiving your application through info.ch@confinis.com. If you wish to contact us directly: Beat U. Steffen, Founder & CEO of confinis ag, +41 26 494 8 494.

Experience

The ideal candidate has 5+ years of experience in regulatory affairs or quality management combined with software engineering in the medical devices, combination products or in-vitro diagnostics industries.

Skills and qualifications

• practical experience with software lifecycle processes for medical device / health software incl. requirements analysis, architectural design, software testing and software maintenance
• interdisciplinary project management (including remediation projects)
• software risk management, cybersecurity, data protection
• requirements engineering and management
• experience in the development of medical devices (including active implantable devices), in-vitro diagnostics (IVDs), and/or combination products / combined products
• medical device software: IEC 62304, IEC 80001, IEC 80002, IEC 82304
• quality management systems: ISO 13485, 21 CFR Part 820, MDSAP (Medical Device Single Audit Program)
• risk management: ISO 14971, safety assurance cases according to FDA guidelines and AAMI TIR38
• experience in international regulatory affairs: device classifications, regulatory and normative requirements
  
• good written and oral communication in German and English

NOTICE TO SEARCH FIRMS/THIRD PARTY RECRUITMENT AGENCIES (RECRUITERS)
Unsolicited resumes sent to confinis from recruiters do not constitute any type of relationship between the recruiter and confinis and do not obligate confinis to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to confinis employees.