- Sumitomo Pharma (Tallahassee, FL)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. ... Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion… more
- Dentsply Sirona (Sarasota, FL)
- …role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and ... technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the...EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and… more
- Stryker (Lakeland, FL)
- …**What You Will Do:** + Investigate customer complaints in accordance with FDA and global regulatory requirements, ensuring timely and compliant resolution. + ... and quality specifications. + Monitor compliance to Medical Quality Procedures, FDA , and other global health authority regulations. + Support field action-related… more
- Sysco (Orlando, FL)
- …declaration for a wide range of products. Ensure adherence of USDA and FDA regulatory labeling for label process integrity. Use of independent judgement concerning ... compliance and development of product specifications. **Duties and Responsibilities:** + USDA/ FDA Label Review for regulatory compliance + Working with product… more
- Prime Matter Labs (Miami Gardens, FL)
- …strategies, drive continuous improvement initiatives, and ensure full compliance with FDA regulations, GMP standards, and ISO requirements. This position requires a ... training, document control and internal audit program. + Ensure compliance with GMP, FDA regulations (21 CFR Parts 210/211), and ISO 22716 for cosmetics and OTC… more
- Compass Group, North America (Gainesville, FL)
- …is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. ... and all other prerequisite food safety standards are met according to USDA, FDA , FSIS, FSMA and corporate requirements. + Must have extensive knowledge of the… more
- Compass Group, North America (Melbourne, FL)
- …(SQF)** systems. This hands-on operational role ensures compliance with USDA, FDA , FSMA, and customer requirements while protecting consumers, customers, and brand ... + Lead internal and external food safety audits (USDA, FDA , GFSI, third-party) + Respond to customer quality and...GFSI auditor certification required + Experience with USDA/FSIS and FDA regulatory standards + Proven success in audit readiness,… more
- Cardinal Health (Tallahassee, FL)
- …documentation in accordance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal procedures. **_Responsibilities_** **Labeling Review & ... work experience, preferred + Working knowledge of cGMP and FDA regulations. + Experience with quality management systems and...decisions in a diplomatic, productive manner. + Knowledge of FDA drug and device listing requirements. + Knowledge of… more
- Stryker (Weston, FL)
- …ensure compliance with internal procedures and regulatory standards (eg SOC 2, ISO, FDA and HIPAA) **Work Flexibility:** _Hybrid_ : Candidates must reside within a ... regulatory and compliance frameworks (eg, SOC 2, ISO 27001, FDA 21 CFR Part 11, HIPAA, ISO 13485). +...or AWS + Knowledge of SOC 2, ISO, HIPAA, FDA , or other related regulatory standards + Solid understanding… more
- Actalent (Deltona, FL)
- …by interpreting physician instructions. + Identify prescriptions that fall outside FDA -approved labeling or program guidelines. + Approve orders exceeding FDA ... retail pharmacy, call center operations, and prescription review. + Familiarity with FDA regulations and pharmacological standards. + Minimum of 1-2 years of… more