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.
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