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.