Gra Md Junior Manager Ae (Regulatory Affairs)

TL;DR

Junior Manager AE (Regulatory Affairs): Supports Global Regulatory Affairs in registering medical devices, conducting re-registrations globally and managing the lifecycle of medical devices with an accent on preparing necessary documents for global registrations. Focus on the correctness of the information provided to managers, departments and authorities.

Location: Hybrid - Office work takes place in Sânandrei, Timis County, Romania. Regular travel to hirify.global Germany (1- 2 / year)

Company

hirify.global protects and improves the health of people worldwide by bringing expertise and sharing innovation, efficiency and sustainability.

What you will do

• Prepare documents for global registrations and re-registrations.
• Respond to deficiency notices issued by regulatory authorities.
• Monitor global registrations and update databases.
• Manage technical documentation according to internal and external standards.
• Support change control activities and prepare documents for customer requests.
• Participate in projects related to process improvement.

Requirements

• University degree in Medical Engineering, Pharmacy, Chemistry, Biology, Medicine, Engineering or related fields.
• Minimum 1 year professional experience
• English - advanced, written and spoken
• Proficient in MS Office applications, Outlook, Adobe Professional / Nuance.
• Good organisational skills, attention to detail, high level of personal responsibility and commitment.
• Excellent communication and teamwork skills, flexibility and resilience.

Nice to have

• SAP knowledge constitutes an advantage
• Willing to travel internationally.

Culture & Benefits

• Fixed-term contract for 2 years.
• Annual performance bonus.
• Work from home half of the time (50%).
• Meal tickets, health subscription, and 7 Card subscription.
• Premium for family events and partial settlement costs for eyeglasses.
• Free coffee and dynamic work atmosphere.