Regulatory Affairs Specialist

A global medical technology company focused on women's health is looking for a Regulatory Affairs Specialist.

Objective:

As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The RA Specialist will assist in the execution of regulatory activities necessary to obtain and maintain regulatory approvals for high vigilance countries. In this role, the individual will ensure compliance with relevant FDA, MDR, ISO and other global regulations.

Requirements:

• University Degree in an applied science or other related area or equivalent experience.
• 4-5 years’ experience in a regulated industry (e.g., medical devices, pharmaceutical).
• Knowledge of GMP’s (Good Manufacturing Practice) is a must.
• Two or more years of experience working in regulatory affairs areas.
• Write and edit technical documents
• English Required. 
• Knowledge of ISO, FDA, CE Mark, Risk Management and other quality standards and regulations applicable to medical devices.