PlusOne

Regulatory Affairs Officer - Medical Devices - Liège

Company

Our Client is a is an innovative Medical Devices company based in Liège. The company has been developing for more than 30 years a range of innovative products, designed in partnership with ophthalmic surgeons and in close cooperation with specialized research centres and universities.

Their expertise covers all steps of development and manufacture of intraocular lenses extending from polymer chemistry to sterilization processes, responding to the strictest requirements in quality.

Role

You are looking for a professional challenge that allows you to work in a start-up environment in order to participate to the registration activities?

You have acquired experience with international submissions in the medical devices industry and you want to participate to international Regulatory Affairs Projects ?

Plus One can offer you this great challenge:

  • Write, edit and review comprehensive regulatory and technical documentation, application dossiers and summaries of technical file.
  • Play an active role in the definition of the registration roadmap and timelines to achieve registration strategy globally
  • Support cross functional alignment initiatives to ensure compliance on Regulatory and Clinical activities
  • Provide technical and product expertise to regulatory and commercial agents for the countries he / she is responsible
  • Handle administratively and keep up-to-date registration files, change notification and tenders for the countries he / she is responsible
  • Maintain submission and technical documentation, licenses and records up-to-date
  • Maintain certification in the countries he / she is responsible
  • Ensure documents are produced in accordance with applicable internal and external procedures, guidelines, regulations and standards
  • Maintain day-to-day distributor relationships (Regulatory)
  • Serve as contact point for regulatory operations in the countries he / she is responsible
  • Report on registrations performance and progress

Profile

  • MSc (or higher) degree in a technical or science discipline, Administrative degree in addition (optional)
  • General knowledge of medical device regulations and Quality Management Systems
  • At least 5-10 years of relevant experience within regulatory function in medical devices industry
  • Experience with:
    • implantable medical device technical documentation formats (for ex. IMPDRF, MDR…)
    • implantable medical device registration globally
    • regulatory, technical, clinical data maintenance and interpretation
    • ISO 13485, ISO 14155, GMP
    • Experience with FDA registration is a plus

  • Skills
    • Sense of responsibilities and ownership
    • Ability to work across function and in an international environment.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Fluent English speaking, writing, reading. Other language(s) would be a benefit.
    • Good computer skills (Microsoft Office package)
    • Assertiveness
    • Multitasks, ability to prioritize and conscious of lead-time.
    • Strong organizational and follow-up skills, as well as attention to detail.

Offer

Our Client offers a full-time permanent position along with an attractive remuneration package.

The position is based in Belgium and has an international scope.

This is an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and team spirit.

Publication date

02.01.2021

Contact person

Gaëlle Minet

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