France Job Openings
BVI Medical
Medical Device project manager
Toulouse
FULL TIME
September 9, 2024
- 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
- 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
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and Phys IOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
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