Clinical Regulatory Specialist

Job Function:    

• Coordinate inspection of the corporation and contract facilities, and develop procedures to ensure regulatory compliance. Support submissions (feasibility OUS, IDE, 510k, PMA)

Description:  

• Oversee short-term and long-term planning of regulatory submission initiatives.
• Interpret corporate policy.
• Develop regulatory strategic plans in conjunction with project teams and assist in the design of nonclinical and clinical study programs required for regulatory approval.
• Prepare responses to inquiries from regulatory authorities.
• Communicate changes and updates to staff and management.
• Prepare and submit applications and reports.
• Regularly reporting on compliance status and measures to both internal and external parties
• Assist in obtaining and maintaining government approval.
• Coordinate with external vendors for project management and regulatory compliance in support of OUS feasibility/IDE trials and 510k/PMA submissions.
• Develop labeling and ensure labeling is in compliance with applicable regulations.
• Stay informed of relevant regulation changes (i.e FDA, MDR, PMDA, etc.) – perform gap assessments for changing regulations to determine impact on AVC procedures.

Training and Experience Required:  

• A minimum of 1 year experience in regulatory affairs.
• Prepare regulatory documents and IRB submission for all protocols.
• Managing activities such as audits, regulatory agency inspections or product recalls.
• Implementing regulatory affairs policies and procedures that regulatory compliance is enhanced.
• Possess strong analytical skills with excellent problem solving abilities.
• Project and time management.
• Strong writing, reading and communication skills.

Education:

•   Minimum of BA degree with science major or equivalent.