Regulatory Specialist

Regulatory Specialist needed for FieldLine Medical located in Louisville, CO. Develop, implement, and maintain regulatory compliance programs to align with the current regulations and to support the company’s business objectives. Create and execute regulatory strategies for new product development and modifications to existing products. Prepare, review, and submit regulatory submissions to global authorities, including the FDA, EU Notified Bodies, Health Canada, and other regulatory agencies (e.g., 510(k), CE marking, Canadian Licenses). Lead and support internal and external audits and inspections, including preparation, participation, and follow-up activities. Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions related to regulatory and quality processes. Contribute to the implementation, maintenance, and continuous improvement of the company’s electronic Quality Management System in accordance with ISO 13485, 21 CFR Part 820, 21 CFR Part 11, IMDRF and other applicable standards. Will assist client located throughout the U.S. Master’s degree in Regulatory Affairs along with 2 years of experience performing the job duties listed above. Must be willing to relocate and travel.