A consulting company for medical equipment companies, companies in the field of digital health and companies engaged in the life sciences. The company’s goal is to help these companies successfully introduce products to the international market and ensure the place of their products in the market. The company Provides consulting services in the areas of regulation, quality assurance and clinical research.
• Define regulatory strategies and pathways.
• Create Technical Files for CE
• Create FDA/510k Submission Files.
• job requirements:
2-5 years’ related experience in the medical device industry.
• Experience in certified QMS environment per ISO13485 / FDA-QSR.
• Bachelor’s degree or higher in life science-related discipline, engineering, or law
• Excellent English proficiency