About our Client
Our client, Nyxoah (https://www.nyxoah.com ), is a health-technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA).
Nyxoah’s lead solution is the Genio® system, a CE-mark validated, user-centered, bilateral neurostimulation therapy to treat moderate to severe Obstructive Sleep Apnea (OSA), the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.
In September 2021, the US Food and Drug Administration (FDA) has granted the Genio® bilaterial hypoglossal nerve stimulation system Breakthrough Devise Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate.
The Breakthrough Designation is supported by data from the Company’s BETTER SLEEP trial, aimed at addressing the long-term safety and performance of the Genio® system in adult OSA patients with and without CCC.
Your role
The Regulatory Affairs Specialist for the EU Region holds a central role in ensuring compliance with EU regulatory requirements for medical devices (and in the assigned geographies). The position involves close collaboration with cross-functional teams during product development, implementation of effective regulatory strategies for product approvals and market access, and ownership of regulatory process.
Location: Belgium
Reporting to: Regulatory Director
Full time
Remote position (presence at the office for monthly/quarterly meetings requested; more frequently on-site presence possible)
Major Areas of Accountability
- Coordinating and compiling high-quality regulatory submissions for Nyxoah products.
- Support registration with appropriate documentation.
- Prepare and maintain the Technical File for submissions to European regulatory authorities.
- Ensure that the regulatory records are accurate, complete and current.
- Research and interpret regulations and standards and ensure that our products comply.
- Supporting the Quality team with regulatory assessments for change controls, complaints, and CAPA
- Actively participate in the preparation and execution of internal audits and external audits conducted by regulatory authorities.
- Assist in coordinating and documenting medical device reporting, post-market surveillance, recalls, and vigilance reporting and update appropriate regulatory agencies as required.
Your profile
Professional skills requirements:
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) or in Regulatory Affairs, preferred.
- 5-7 years regulatory experience in Medical Device industry (Class II-III devices).
- Experience with submissions to regulatory authorities.
Attributes:
- Good working knowledge of ISO 13485 guidelines, standards, GMP, MDR requirements.
- Work well in cross-functional teams, independent yet passionate, good communication skills and a team player.
- Demonstrate a continuous desire to identify, learn and understand up-to-date regulatory requirements, best practices, and trends and apply with practical solutions.
- Analytical and data driven.
- Maintain extremely high attention to detail and follow through.
- Effective organizational skills
- Proficient in Microsoft Office including Outlook, PowerPoint, Word, and Excel
Our client's offer
Beyond a competitive salary and attractive benefits, our client offers you a challenging opportunity in an agile company.
Person in charge
Morgane de Jong - Recruitment Consultant
Office : +32 010 39 21 88
Mail : mdejong@plusonesearch.be