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Technical Product Manager

vor 3 Monaten

Aesch BL, Basel-Land, Schweiz unisite ag Vollzeit

unisite ag is a service provider in the field of Employer Branding & Talent Management. We provide consulting services to clients in the chemistry, pharmaceutical, biotech, medical device, and life sciences industries.

Our client, Pentapharm AG, is an international and innovative company and is part of the DSM Firmenich Group. They employ approximately 150 people and specialize in the production and global sale of active ingredients for the pharmaceutical and diagnostics industries.

On behalf of our client, we are currently looking for a:

Technical Product Manager & Project Manager R&D (m/f/d)

Location: Aesch, BL

Position

We are seeking a highly skilled and motivated individual to join our team as a Technical Product Manager & Project Manager R&D. The successful candidate will have a strong background in In Vitro Diagnostics (IVD), European Medical Regulation, and ISO 13485. This role also requires part-time work in the laboratory to perform performance and IVD tests such as Stability follow-up.

Tasks
  • Develop, write, and edit technical materials such as equipment manuals, appendices, or operating and maintenance instructions for IVD
  • Ensure compliance with European Medical Regulation and ISO 13485 in all technical documentation
  • Collaborate with subject matter experts to ensure accuracy of product descriptions
  • Management of R&D projects for the development of new assays
  • Conduct performance and IVD tests, including stability follow-up
  • Document all laboratory procedures and results
  • Ensure all laboratory activities comply with safety protocols
Qualification
  • Completed academical studies in a related field
  • Proven experience as a Technical Writer in the IVD industry
  • Familiarity with European Medical Regulation and ISO 13485
  • Experience in the application of project management
  • Familiarity and experience in the field of haemostasis
  • Experience in a laboratory setting, conducting performance and IVD tests
  • Strong attention to detail
  • Strong written and oral communication skills in English, German is of advantage

Seize this opportunity to shape your future - we look forward to receiving your application