- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assists in the writing of regulatory applications to the FDA and other regulatory bodies + Partners ... specifications for new product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project + Manages all aspects… more
- Oracle (Harrisburg, PA)
- …of Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and ... Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. -...maintaining compliance to FDA and other Global regulatory requirements. - Proficiency in the Java programming language.… more
- Globus Medical, Inc. (Eagleville, PA)
- … requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes, policies, and rules is… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- Fujifilm (Harrisburg, PA)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Omnicell (Cranberry Township, PA)
- …to enhance and optimize internal training processes. + Lead external audits and regulatory inspections, ensuring full compliance with ISO, FDA , and other ... Management discipline + Expert-level knowledge of QMS processes and regulatory standards (ISO 13485, FDA , etc.) +...QMS processes and regulatory standards (ISO 13485, FDA , etc.) + Demonstrated ability to lead large-scale projects,… more
- PCI Pharma Services (Philadelphia, PA)
- …in a regulated environment + Demonstrated expertise in quality management systems and regulatory requirements ( FDA , ISO 13485, Medical Device Directive) + Strong ... the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role leads the implementation,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Philips (New Kensington, PA)
- …right fit if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and execute the...EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA… more
- University of Pennsylvania (Philadelphia, PA)
- …and serve as a key departmental stakeholder representing the department/division related to regulatory audits by the FDA , EMA, other Competent Health Authorities ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more