R&d Project Manager
Il y a 4 mois
**Job Requisition No**
VN8086
**Work Location Name**
France - Toulouse (Arcadophta)
**Worker Basis**
Full Time
**Worker Type**
Employee
**Applications Close Date**
Oct 20, 2024
**Purpose**
- Are you ready to take 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. Your expertise will help shape the future of our product line, ensuring compliance and excellence in every step. Please note this is a maternity cover for a 10-month contract.
- **Key Responsibilities**
- Monitor project documentation to meet Design Procedure standards
- 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
**Qualification**
- 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
**Company**
BVI® is refocusing the future of vision.
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 PhysIOL® (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.
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