Senior Consultant (f/m) – Quality Management and Regulatory Affairs for Software in Medical Devices and Combination Products and Software as a Medical Device

confinis is looking for a subject matter expert in the field of quality management and regulatory affairs for software in medical devices and combination products as well as software as a medical device. Your willingness to expose yourself to promote your competences but also yourself as a person will be one of your success factors and contribute to the way we are working with our clients and partners. If you enjoy contributing with your expertise hands-on to the success of our clients and at the same time also appreciate being part of the confinis team of consultants building a network you can rely on, we invite you to get in contact with us to discuss your opportunities.

Department: Regulatory Affairs
Project Location(s): Switzerland
Education: Bachelor / Master / PhD

Responsibilities

  • provide consulting and support in your individual specialized field of expertise according to the clients’ needs
  • take over the role as project leader comprising key account responsibilities
  • being the primary contact for the client
  • secure internal data maintenance in applicable documentation systems
  • secure smooth project progress
  • close the projects and secure required reporting
  • be engaged in mandate acquisition
  • give presentations in the individual specialized field of expertise for clients, at conferences or for educational purposes (e.g. Institutions, Universities etc.)
  • provide trainings and workshops in the individual specialized field of expertise for clients or as event organized by confinis
  • contribute content to digital marketing and conventional 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 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.

 

NOTICE TO SEARCH FIRMS/THIRD PARTY RECRUITMENT AGENCIES (RECRUITERS)
The CEO manages the recruitment and employment process at confinis. 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.

Experience

The ideal candidate has 10+ years of experience in regulatory affairs, quality management combined with engineering for software in devices or software as a medical device in the medical devices, device constituent part of combination products or in-vitro diagnostics industries.

Management Skills

  • interdisciplinary project management (including remediation projects)
  • product lifecycle management
  • software lifecycle Management
  • risk management and cybersecurity
  • requirements engineering and management

Devices Knowledge

  • medical devices (including active implantable devices)
  • in-vitro diagnostics (IVDs)
  • combination products / combined products

Special Knowledge/Skills

  • quality management systems: ISO 13485, 21 CFR Part 820, MDSAP (Medical Device Single Audit Program)
  • medical device software: IEC 62304, IEC 80001, IEC 80002, IEC 82304
  • risk management: ISO 14971, safety assurance cases according to FDA guidelines and AAMI TIR38
  • cybersecurity according to respective FDA guidelines
  • connected health
  • international regulatory affairs: device classifications, regulatory and normative requirements
  • end to end product lifecycle management
How can we help you?

Call us at a confinis office nearest to you or send us a message online.

Peschke appreciates the specialized expertise for regulatory challenges in the area of combination products. For us this missing piece is key to success to access the important US market. The professionality and expertise of confinis is overwhelming, and we can highly recommend them whenever FDA related topics occur – Great people behind a great business!

Yvette Viscuso
Managing Director, Peschke Trade

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