PlusOne

R&D Lead - Medical Device - Liège

About PlusOne

PlusOne is the first recruitment office entirely dedicated to SMEs active in the field of science or technology in Belgium. Your SME, start-up or spin-off is looking for new staff and doesn’t have enough time or competent resources necessary to handle recruitments? Hiring the services of a recruitment firm comes with a cost and you fear you may not find the right contact to deliver the results?

PlusOne offers you highly qualitative direct search hiring services. We are trained to understand the most complex profiles and to identify them on the Belgian or foreign job market. We know that the needs of an SME are different than those of large companies and we factor that in our selection of candidates. Our aim is to help you find the resource that will allow your core business to continue to develop. We can take charge entirely or partially of the recruitment process so that you can stay focused on the heart of your activity: we do our job so you can do yours !

Company

“As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio spans more than 115 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.”

Role

  • Responsible of “chemistry and biomaterial” R&D projects related to new products development (ex. new coating for IOL implantation accessories)
  • Responsible for “chemical” activities associated to the manufacturing process improvement (ex. optimization of IOLs purification process)
  • Develop and establish new analytical methods for in-process control (ex: extractables control)
  • Develop and establish methods for products performances validation (ex: physico-chemical of biomaterial)
  • Responsible for biocompatibility validation process and other biological safety concerns of all materials involved in our products according to ISO 11979-5 and 10993-18 standards
  • Support to QC, QA and RA departments for implementation of Design Control (DCP, DHF, DMR…) and other validation procedures in compliance with ISO, GMP standard and MDR regulation (optionally)
  • Contribute to optimize documentation related to R&D, QA, QC, RA and design transfer
  • Involved in the process transfer of new products and new control methods in close interaction with industrialization and QC departments.
  • Expertise/advisor for all chemistry, toxicological and biocompatibility aspects in our risk management process
  • Involved in the qualification of service providers for outsourced V&V process

Profile

  • Expertise in polymer biomaterial, medical device (2b,3) and chemical analytical method
  • Experience in biomaterial development and characterization (organic chemistry, extractables-leachable analysis, physico-chemistry)
  • Experience in the development of analytical (method development, review of results, protocol redaction, specification definition)
  • Experience in GMP manufacturing (risk assessment, process transfer, scaling-up, process validation)
  • Experience in implantable medical device (Class 2b, class 3) development (design history file, design control…)
  • Knowledge in laboratory analytical (HPLC, GC, DSC, TGA, SEC, NMR, IR and UV)
  • Experience in scientific advice with authorities (EU Notified body, ANSM, Bfarm, MHRA, FDA…)
  • Knowledge and application of GMP and ISO 13485 regulations
  • Min Master degree Chemistry or Pharmacist
  • 5 years exp
  • Min 2 years exp private sector

Soft skills:

  • Solution oriented
  • Experience in team management
  • Well-organized, easiness of assimilation of new technics
  • Can adapt to rapid changes of priorities and organization (flexible)
  • Collective intelligence

Offer

  • You are joining a dynamic, fast-growing environment at the cutting edge of technology and innovation in a company with great human values, which encourages its teams to take initiatives and contribute ideas that contribute to its success.

Publication date

28.09.2021

Contact person

DORTU

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