Regulatory Affairs Specialist - II

Job Title : Regulatory Affairs Specialist - II

Job Location : 100% Remote

Job Duration : 3 Months+ (Possible extension)

Job Description :

• The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements.
• As a regulatory process expert supporting global registrations the candidate interprets federal / state / international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies.
• Investigates and resolves compliance problems, questions and complaints.
• Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes.
• Determine the need for and prepares regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and / or approval and appropriate country licenses and certificates for new products and / or changes to existing products.
• Respond to regulatory agency inquiries. Knowledge of product history, profile, specifications, standards, safety issues, precedents and approval.

Job Duties :

• Investigate regulatory history of similar products to assess approval implications.
• Meet and follow policies and procedures to complete milestones.
• Communicate with internal technical (engineers / scientists) and regulatory personnel.
• Interpret and evaluate data. Write and edit technical documents. Prepare and submit IVDR documentation.
• Prepare and submit Global registration documentation.
• Electronic submission process, types and requirements (CLARA).
• Monitor applications under regulatory review. Maintain regulatory files. Import / export requirements.
• Update and maintain paper / electronic document archival systems.
• Determine product regulatory path or class. Evaluate design changes for regulatory filing strategies.
• Assess regulatory impact and risk. Develops plan for timely renewal registrations to ensure continued product supply.
• Communicate closely with the Headquarters on the needs and problems of registration documentation and registration test.

EDUCATIONAL REQUIREMENTS : Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 3 -5 years of experience in the offered position or related.