Job Responsibilities
- Prepare, review, file, and support premarket documents for global registrations for assigned projects.
- Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
- Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization.
- Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
- Develop Regulatory Strategies for new or modified products for assigned projects.
- Monitor and provide information pertaining to the impact of changes in the regulatory environment.
- Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
- Document, consolidate, and maintain oral and written communication with health authorities.
- Prepare internal documents for modifications to devices, when appropriate.
- Participate in health agency inspections & notified body audits as necessary.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
- Assist in development/maintenance of regulatory files, records, and reporting systems for systematic retrieval of information.
- Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
- Ensure compliance with regulations specific to clearance and approvals of MEIC-developed product’s raw material and/or prototype.
