Regulatory Affairs

• Participate in the development of regulatory submission and approval strategy in multiple countries.
• Maintain awareness and understanding of new and existing regulatory requirements.
• Support identification of applicable regulatory requirements their impact and how to interpret them.
• Support on generating the required documentation for various submissions
• Assemble regulatory submission package and support submission process.
• Support audits and inspections by regulatory authorities or notified bodies.
• Assist in the creation revision and maintenance of QMS documentation including SOPs work instructions and forms.
• Support the coordination and documentation of employee training related to the QMS and regulatory requirements.
• Assist in the administration and tracking of Corrective and Preventive Actions (CAPA).
• Participate in continuous improvement initiatives to enhance the effectiveness of the QMS.

regulatory affairs,documentation,forms,maintenance