Junior RA-QA specialist

Barcelona, Spain    ·     Full time

We are looking for an exceptional junior RA/QA specialist. The successful candidates will join the RA/QA team and will participate in the maintenance of the quality management system and in the preparation of regulatory documents and submissions that ensures the compliance of Neuroelectrics’ products and activities with applicable legal and regulatory requirements worldwide.

Start date: ASAP

We are currently looking for a Junior RA/QA specialist for our RA/QA team. We offer a full time job in the forefront of applied neuroscience in a medical device company with a focus on bringing new technologies to bear on real-world clinical application. We believe we are driving a revolution in how we measure and modulate the activity of our electrical brains, which will have a massive impact on health, wellness, human-computer interaction, and society.

Required education:

• B.S. degree, preferably in a scientific or technical discipline

Responsibilities:

• Support in the maintenance of the company Quality Management System.
• Coordinate the preparation of technical and regulatory documentation in support of new products certifications/registrations.
• Maintenance of the Technical Files, and related documents pertaining to already certified/approved medical Devices (CERs, PSURs, IFUs…).
• Provide input to development teams to assure that regulatory requirements and standards are incorporated in the product development process.
• Review promotional material and labeling to ensure applicable regulatory requirements are met.
• Keep abreast of new or changes in the regulations of EU, FDA, Health Canada, and other territories of interest.
• Support regulatory compliance of commercial activities.
• Support worldwide registration.
• Other duties as assigned.

Requirements:

• Knowledge of ISO 13485 and FDA QSR.
• Familiarity with Medical Device Regulation, CE mark and FDA pre-market submissions.
• Familiarity with Vigilance Reporting, PMS activities and medical Device labelling requirements.
• 1-2 years’ experience in Medical Devices Quality systems and/or Regulatory Affairs will be an asset.
• Technical knowledge of medical devices.
• Familiarity with the development and manufacture of medical devices.
• Familiarity with Quality management Systems for Medical Devices.
• Proficiency with PC computer and Microsoft Office software.
• Fluency in English both written and oral.
• Strong organizational and interpersonal skills.
• Strong written and oral communications skills (English, Spanish).
• Detail orientation.
• Ability to manage multiple projects with shifting priorities.
• Ability to work independently.

Please click here to apply.