R&D Project Manager

il y a 4 semaines


Toulouse, Occitanie, France Physiol Temps plein
Job Details:

R&D Project Manager - Medical Devices

Join our team at PhysIOL, a leading company in the surgical ophthalmic industry, as we embark on a pivotal role in our Research & Development team. As an R&D Project Manager, you will lead the charge in managing technical files and driving the certification process for our innovative products.

Key Responsibilities:
  • Monitor project documentation to meet Design Procedure standards
  • Participate in enhancing both existing and new products through the application of scientific results
  • Write and approve protocols and reports for biocompatibility studies and validation of ophthalmic products
  • Operate within ISO 13485 and 10993 standards to ensure top-notch quality
  • Prepare necessary documentation for product certification and EU 2017/45 MDR files
  • Contribute to establishing risk analyses
  • Collaborate with ARCAD employees (quality, purchasing, sales, validation) and BVI employees (R&D, HR, IT, Marketing, Sales), as well as suppliers, sub-contractors, health authorities, notified bodies, surgeons, and specialists
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related field
  • Minimum of 3-5 years of experience in R&D, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry
  • Fluent in French with knowledge of English (least written proficiency)
  • Proven experience in drafting and managing certification files for drugs or medical devices
  • Strong understanding of ISO 13485 and ISO 10993 standards and EU MDR 2017/45 regulations
  • Proficiency in using MS Office suite, particularly Excel and Word
  • Experience in risk analysis and quality management processes
About PhysIOL:

We are a purpose-built portfolio of trusted brands, including Beaver, Visitec, Malosa, Vitreq, and PhysIOL, spanning more than 90 countries. Our goal is to touch the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. We trust and empower our associates to make decisions and solve problems because collaboration drives us. We value agility, simplicity, and transparency, and we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.


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