- University of Miami (Miami, FL)
- …the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA . + Tracks proposals and other study ... This role is also responsible for the independent execution of regulatory -related decisions/strategies and coordinates work with study managers and other relevant… more
- Terumo Medical Corporation (Somerset, NJ)
- …with US Food and Drug Administration ( FDA ) regulations, international regulatory requirements, company policies, operating procedures, and quality system ... labeling requirements across US and international markets and ensures compliance with FDA , Terumo, and global regulatory standards. The Senior Labeling… more
- Bristol Myers Squibb (Indianapolis, IN)
- …planning through execution, manages a cross-functional team, and ensures alignment with regulatory requirements (cGMP, FDA , USP, and other relevant bodies). The ... + Strong knowledge of pharmaceutical validation practices, including cGMP and FDA /USP/OSHA regulatory requirements. + Expert understanding of facility, utility,… more
- Terumo Medical Corporation (Caguas, PR)
- …required. Experience managing medical surveillance programs, case management, and regulatory compliance (OSHA, HIPAA, FDA , or equivalent) preferred. ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Dentsply Sirona (Charlotte, NC)
- …design for reader and standalone studies for AI models. + Collaborate with R&D, Quality , Regulatory , and product marketing teams to ensure clinical relevance and ... portfolio of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and deliver better… more
- GE HealthCare (Madison, WI)
- …Compliance** : Ensure programs adhere to global regulatory requirements (eg, FDA , CE Mark) and GE Healthcare's quality standards. + **Continuous ... ability to solve complex problems and make data-driven decisions. + Familiarity with regulatory standards (eg, FDA , ISO 13485) and healthcare compliance. +… more
- Actalent (Franksville, WI)
- …Collaborate closely with cross-functional teams, including mechanical engineers, process engineers, quality , and regulatory teams, to ensure device safety, ... + Understanding of process validation and statistical analysis. + Knowledge of quality management system requirements. + Understanding of FDA Design Controls… more
- AbbVie (North Chicago, IL)
- …systems are installed, commissioned, qualified, and maintained in compliance with regulatory requirements, internal quality standards, and industry best ... + Strong knowledge of qualification and validation lifecycle principles and applicable regulatory guidelines ( FDA , EMA, ICH Q7/Q9/Q10, GAMP 5, ASTM E2500).… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Perform design ... for rapid prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other...to maintain compliance and product performance. + Collaborate with Quality , Regulatory , Manufacturing, and Supply Chain teams… more
- University of Pennsylvania (Philadelphia, PA)
- …with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures (SOPs), ... Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously....review organizations, most notably the Food and Drug Administration ( FDA ). In addition to clinical trial management, the Director… more