Country: Hungary
Functional area: Medical Technology
A rare and exciting opportunity to be part of a global life sciences software solution provider as an MDR Subject Matter Expert and joining their team in Budapest.
The role will liaise with major pharmaceutical companies and regulagory leaders within Europe.

Responsibilities:
  • Working operationally and strategically with Product owners and customers to understand business requirements
  • In projects, provide regulatory expertise and guidance on procedural and documentation requirements
  • Analyze and synthetize requirements and impact of various scenarios
  • Be the regulatory advisor for Engineering team
  • Track regulatory updates from different Health Authorities and inform thecustomers
  • Provide Trainings and Conduct workshops

Requirements:
  • Strong experience of MDR and strong knowledge in EMA and FDA regulations
  • Knowledge of RIMs tool or Extensive experience in managing medical device regulatory compliance products
  • Conducting projects efficiently and proactively
  • Collaborating with multinational project teams
  • Strong knowledge of English both in oral and written
  • Working with cross-functional working groups as needed Functional and ITskills

Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.
A rare and exciting opportunity to be part of a global life sciences software solution provider as an MDR Subject Matter Expert and joining their team in Budapest.
The role will liaise with major pharmaceutical companies and regulagory leaders within Europe.

Responsibilities:

  • Working operationally and strategically with Product owners and customers to understand business requirements 
  • In projects, provide regulatory expertise and guidance on procedural and documentation requirements
  • Analyze  and synthetize  requirements and impact of various scenarios 
  • Be the regulatory advisor for Engineering team
  • Track regulatory updates from different Health Authorities and inform the customers
  • Provide Trainings and Conduct workshops

Requirements:

  • Strong experience of MDR and strong knowledge in EMA and FDA regulations
  •  
  • Knowledge of RIMs tool or Extensive experience in managing medical device regulatory compliance products
  • Conducting projects efficiently and proactively 
  • Collaborating with multinational project teams 
  • Strong knowledge of English both in oral and written
  • Working with cross-functional working groups as needed Functional and IT skills

 
Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.
 MDR English Regulatory