Regulatory Affairs Specialist

The Regulatory Affairs position within Regulatory Policy & Intelligence (RP&I) is responsible for  contributing to or leading impact assessments and for changes to regulatory requirements, assessing applicability regarding regulatory submissions and procedures, and assessing the timeline for implementation of changes. This role may also help monitor for changes to regulatory requirements and working with other Subject Matter Experts to ensure requirements are appropriately translated into the quality management system. This position may require support from senior Regulatory Affairs members and/or managers.

This role can also be based in St. Louis.

Job Duties

• Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.
• Perform and/or assist in the completion of the following tasks:
• Monitoring of changes to existing regulatory requirements or identifying new regulatory requirements.
• Assessment of impact of new or revised regulatory requirements.
• Collaboration with SME’s to provide feedback and/or create supporting documentation to ensure product deliverables meet Health Authority expectations.
• Coordination with global/local RA counterparts to ensure that changes to regulatory requirements are understood.
• Conduct research about new regulations and guidance documents.
• Development and review of corporate and department procedures.
• Assist or participate in audits when needed.
• Support or lead in understanding regulatory requirements and identify solutions; provide possible suggestions for implementation.
• Ensures accurate tracking of new or revised regulatory requirements.
• Lead and/or coordinate meetings and guide discussions regarding regulatory topics.

Qualifications:

Bachelor’s Degree required. Science background is preferred.

Specialist:

3+ years in regulatory affairs, medical device/IVD industry required.

3+ years in FDA environment preferred.