Provide regulatory input to new product development and product lifecycle planning

Generation of documentation and procedures relating to product development, manufacturing, and quality control in accordance with regulatory standards

Ensure compliance with regulations (21 CFR 820), standards (ISO 13485), and the quality manual

Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and provide regulatory advice to project teams as required (Example: DHF/Technical Documentation maintenance)

Review documents, including Clinical Evaluation reports, risk analysis, FMEA, reports, labeling, advertising, promotion and marketing literature

Assist with document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures

Maintain regulatory files in a format consistent with requirements

Assess the acceptability of quality, preclinical and clinical documentation for regulatory submission filing

Monitor applications under regulatory review

Communicate application progress to internal stakeholders

Communicate preapproval compliance activities

Ensure compliance with product post-marketing approval requirements

Ensure external communications meet regulations

Identify emerging issues

Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary)

Provide MDR updates/guidance to product development teams