Responsibilities :
- 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 prepare 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.
- 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.
- 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.
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.
- Strong work ethic with an ability to work independently.
- Possess the ability to read, understand, and summarize technical and scientific information.
- Ability to interpret and apply regulations to company policies and procedures.
- Demonstrated ability to review and interpret design control documentation such as verification and validation test protocols / reports, risk management reports, and product labeling.
- Pragmatic with strong problem-solving skills.
- Experience working with cross-functional product development teams to ensure regulatory compliance.
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