Project Manager, Regulatory Affairs (RA)
Position Overview
This position is responsible for obtaining regulatory approvals and ensures compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties:
- Develops and executes the regulatory plan.
- Represents Regulatory on product development and process/systems improvement project teams and partners with cross functional team members.
- Identifies regulatory requirements for the markets identified in the regulatory strategy.
- Writes, reviews and files regulatory submissions and dossiers to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
- Communicates with regulatory agencies on administrative and routine matters.
- Documents, consolidates and maintains verbal and written communication with the regulatory agencies.
- Reviews change order documents and ascertains impact on current regulatory approvals.
- Reviews and approves promotional material and labeling for regulatory compliance.
- Develops and maintains regulatory processes and leads department process improvements.
- Supports and contributes into developing, editing or revising regulatory processes.
- Supports training for global regulatory processes and system implementations.
- Builds team cohesiveness by influencing and mentoring team members.
- Performs other duties and responsibilities as assigned.