Senior Regulatory Specialist
This role requires a skilled professional to ensure compliance with regulatory requirements across the organization.
* Main Responsibilities:
* Develop and execute strategic plans for regulatory compliance, product registration, and approval.
* Manage day-to-day regulatory activities and handle multiple projects related to regulatory compliance enhancements.
* Promote the implementation of effective quality management systems (QMS) and product development processes.
* Collaborate with cross-functional teams to integrate regulatory requirements into QMS and product development processes.
* Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.
* Maintain current knowledge of changing regulations, guidelines, and industry trends.
* Ensure the highest level of quality within the organization by assessing overall risk profiles and creating programs/tools to mitigate potential risk.