DirecciónAcerca de nuestro cliente
Important company who develops and markets medical post-processing software products
Descripción de la oferta
The Regulatory Affairs Specialist will join a team of highly skilled specialists in Regulatory and Quality affairs. The team is responsible for the QMS system maintenance and regulatory submissions of the products.
Main responsibilities
- Ensure that the company's products comply with the regulations of the countries we are marketing our products
- Keep up to date with national and international legislation, guidelines, and customer practices
- Evaluate applicable laws and regulations to determine impact on company activities
- Ensure accurate timely submissions to regulatory agencies
- Assist with the preparation and submissions of regulatory dossiers
- Prepare submissions of licence variations and renewals
- Proactively collaborate with the Quality Assurance Team to meet product regulatory requirements, including data generation and completion of required dossiers for product approval
- Train company staff in matters related to Regulatory Affairs
Perfil buscado (h / m)
- Minimum of a Bachelor's Degree in a scientific field such as Biochemistry, Chemistry, Pharmacy or Molecular Biology or engineering, computer science, bioengineering
- 2 years' experience in working in a quality department ISO
- EU and / or FDA clearance procedure experience will be highly valued
- Excellent written and verbal communication skills, with the ability to effectively communicate regulatory information in English
Qué ofrecemos
Offices in Barcelona city
Careers oppurtinities and professional development
Two days of teleworking a week
- Leading technology company in our market
Hace 1 hora
