Regulatory Affairs Associate

Job Summary (Regulatory Affairs Specialist)

- Provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment. - Review and analyze labeling, advertising, and promotional materials, collaborating with Marketing for regulatory strategy and compliance input. - Assist with the development and review of promotional content to ensure compliance before distribution. - Contribute to the creation and review of Regulatory Affairs Ad & Promo Standard Operating Procedures (SOPs). - Support regulatory activities related to new product introductions (NPI) and existing market products, including submissions for 510(k), PMA, Health Canada, and Latin America. - Communicate promotional content and approval requirements to cross-functional teams. - Assist in maintaining compliance with product post-marketing approval requirements as needed. - Participate in worldwide regulatory submissions as opportunities arise. - Work cross-functionally with various business units to achieve regulatory compliance. - Ensure all tasks are performed with attention to detail, adhering to ethical and regulatory standards. - Contribute to project management activities, including creating project plans and tracking timelines. - Analyze and organize complex regulatory information, exercising sound judgment in compliance practices.