Human Resources Business Partner
at
Raytheon
Dubai, Dubai, United Arab Emirates - Full Time
Specialization
As an innovative and internationally oriented manufacturer of premium implants for eye surgery, we develop, produce and distribute medical devices to restore the best possible vision to the human eye.
To strengthen our team at our Erlangen location, we are looking for a full-time employee to start as soon as possible.
Regulatory Affairs Specialist (M/F/D)
YOUR TASKS
Approval and registration of medical devices in national and international markets
• Preparation of documents for authentication and legalization
• Support in maintaining and collaborating on the creation of technical product documentation, including risk management files and regulatory documents within the framework of international regulatory strategies.
Project support for implementing the requirements of the new EU Medical Device Regulation and support in maintaining the corresponding approvals.
• Internal contact person and contact person for business partners regarding regulatory issues
• Regulatory assessment of product and document changes relevant to approval
• Support in revising and creating RA-relevant QM documents
• Support in ensuring compliance with all guidelines, laws, standards and country-specific requirements
• Research of guidelines and laws
• Close internal communication and coordination with other departments
Experience Required
Minimum 11 year(s)