- Jabil (West Chester, PA)
- …impact and foster vibrant and diverse communities around the globe. Are you experienced in Medical Device Regulatory Compliance ? Jabil is seeking a ... qualified Medical Device Regulatory Compliance Lead to work in our West Chester, PA site. As the Medical Device Regulatory Compliance … more
- Globus Medical, Inc. (Audubon, PA)
- …improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance , and quality assurance ... accuracy and resolving outstanding lot inspections. + Work with Regulatory teams (US and international) to ensure compliance...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …5 years of proven experience in regulatory affairs, ideally within the medical device or pharmaceutical industry. + Strong understanding of FDA regulations, ... audits, both internal and external. + Prepare various regulatory compliance reports for submission to government...as well as state and international regulations related to medical devices. + Demonstrate ability to maintain regulatory… more
- Fujifilm (Harrisburg, PA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US government… more
- Merck (West Point, PA)
- … Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, ... launch in alignment with the company's business goals, and quality and regulatory compliance . **Essential Duties and Responsibilities:** + Utilize extensive… more
- Jabil (West Chester, PA)
- …meetings (eg, CAC, TIC, MIC, QIC). + Engage in internal/external audits and regulatory compliance activities. + Provide training and guidance to manufacturing ... Quality Engineer, you will support key quality systems, ensure compliance with internal and regulatory standards, and...Quality Engineering (eg, CQE) is a plus. Benefits + Medical , Dental, Prescription Drug, and Vision Insurance with HRA… more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes...orthopedic medical devices; + Experience in medical device development and registration of products… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance . Monitors and improves tracking and… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes… more
- West Pharmaceutical Services (Exton, PA)
- …5 years Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and ... legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global... compliance information and data as required for regulatory compliance and submissions to North America,… more