Product Regulatory Lead R&D

工作内容

iSTAR Medical SA, founded in 2011 and headquartered in Wavre, Belgium, is a pre-commercial stage, medical technology company focused on the development of MINIject, a novel minimally-invasive ophthalmic implant (MIGS) for patients with glaucoma. MINIject is expected to become commercially available in 2021.

We are hiring a Product Regulatory Lead R&D

Reporting to the VP R&D, the Product Regulatory Lead R&D is in charge of writing technical documentation to support Clinical Study Approvals, CE marking and FDA submissions and registrations. She/He ensures compliance of product technical documentation with regulatory and industry standards and ensures that Regulatory Standards are met as part of the Product Development Process.

Your main Responsibilities :

• Own technical/non-clinical product-related documentation according to Design Verification and Validation plan
• Write technical documents including Investigator Brochures, Product Risk Analysis, Verification & Validation Reports, and others as required
• Coordinate cross-departmental activities needed for successful technical document creation and submission
• Prepare technical documentation to support Clinical Study Approvals, CE-Mark applications, FDA regulatory submissions, and product registrations
• Work closely with Quality Assurance, Quality Engineering, and Quality Control in manufacturing to support validation strategies (processes and test methods)
• Maintain technical documentation to ensure compliance with internal QMS, regulations, and standards
• Prepare and present technical documentation in audits (internal and external, i.e. by Notified Bodies).
• Manage Product Lifecycle Management activities, re-submissions and amendments
• Support product registration processes

As the successful candidate, you have the following profile:

• Master’s degree, preferably Ph.D. degree in Science, Engineering or similar
• Strong technical writing skills in English (Investigator Brochures, Risk Management Reports, Technical Reports)
• Previous experience (5+ years) supporting or in Regulatory Affairs for Medical Devices Class, preferably IIb or III,
• Experience with and knowledge of applicable standards and regulation, such as ISO13485, Medical Device Regulations (MDR), FDA guidance documents, etc.
• Experience with Design Controls
• Fluent in English, written and spoken. Knowledge of another language is beneficial
• Good knowledge of Microsoft Office applications
• Excellent presentation skills

What do we offer?

We offer a full-time permanent position along with an attractive remuneration package.

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

Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven tracks records in the pharmaceutical and medical device industries.

We have an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.

Excited about the role?

please send your CV