RAS635

Assess business and legal responsibilities associated with device product listing, facility registration, post-market surveillance and complaint handling, MDRs for adverse events, recalls/corrections/removals, import/export, and medical device tracking.

Develop adverse event documentation that complies with quality regulations.

Implement the concepts and application of corrective and preventive action (CAPA) and root cause analyses in monitoring field performance of healthcare products.

Explain regulatory issues clearly and implement strategies for effective communication of negative information to multiple audiences.

Examine labeling and advertising for regulatory compliance.

Develop strategies for minimizing liability and present alternative approaches.

Identify stakeholders associated with global product compliance.

Research and advise on business, technical and ethical considerations as it relates to global product compliance, field actions, and enforcement actions.