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Product Regulatory Affairs Specialist

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Medical Device - Wavre

Founded in 2011, iSTAR Medical is a clinical-stage medical technology company that aims to provide leading patient care through the design, manufacturing and marketing of novel ophthalmic therapies.

iSTAR Medical develops innovative ophthalmic implants for patients with glaucoma. The ophthalmic implants are made from proprietary STAR® material, a technology from the University of Washington in Seattle (USA). For additional information about the company and the technology, please visit http://www.istarmed.com/

In order to support the development of the company, we are currently looking for a (m/f) :

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Product Regulatory Affairs Specialist

Responsibilities:

As Product Regulatory Affairs Specialist, you are in charge of writing the technical documentation to support clinical study applications, CE marking and FDA registration. You insure compliance of product technical files with regulatory standards and provide support to ensure that regulatory standards are part of the Product Development Process.

Your main responsibilities are:

  • Write technical documentation including Investigator Brochures, Clinical Protocols, Product Risk Analysis, Biocompatibility Risk Assessments.
  • Prepare technical files for Clinical Studies filings, CE-Mark applications and FDA registrations.
  • Maintain technical documentation to ensure compliance with internal QMS and Regulatory Standards.
  • Support R&D and Manufacturing to define the product/process validation strategies in compliance with Regulatory Standards.
  • Ensure that normative and regulatory changes are identified in a proactive manner and coordinate actions plans.
  • Manage product registration processes.
  • Report work evolution on a regular basis.
Profile:
  • Master’s degree or Ph.D. degree in Science or equivalent through experience.
  • At least 5 years of experience supporting Regulatory Affairs for Medical Devices Class IIb.
  • Strong technical writing skills (Investigator Brochures, Clinical Study Protocols, Risk Management).
  • Good knowledge of Microsoft Office applications.
  • Excellent interpersonal, communication and presentation skills.
  • High level of attention to detail, excellent organizational skills and time management, flexibility.
  • Fluent in English, written and spoken. Knowledge of another language is an asset.
  • Willing to travel abroad occasionally.
Offer:
  • A full-time permanent position within a high-potential medical device company with direct impact on the lives of patients.
  • A professional, dynamic and stimulating work environment.
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with the position responsibilities and your experience.
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