- 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 Quality Systems & Compliance Lead for Medical Device ..., you will manage, as an individual contributor, all Regulatory Compliance activities at the assigned sites.… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …Proficient + Computer skills - Proficient + Working knowledge of FDA regulations & other medical device regulatory compliance requirements - Proficient + ... necessary, to support the site ramp up plan. Ensure compliance with regulatory policies and standard: manage...+ Strong practical work experience (8+ years); experience in medical device , food or drug industries preferred.… 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
- Actalent (San Diego, CA)
- …of new and revised labeling. Required Skills: + Experience in medical device labeling and regulatory compliance + Proficiency in graphic design ... labeling process for both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires cross-functional collaboration to… more
- Medtronic (Milwaukee, WI)
- …cost control, waste reduction and inventory control; NC & CAPA Investigations; Medical Device Quality & Regulatory Compliance (FDA 21 CFR Part 820, ISO ... least two (2) years' experience with each of the following: Manufacturing in medical device industry including Class I, Class II and Class III devices; Cleaning… more
- AbbVie (Irvine, CA)
- …works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and ... influence, and provide strategic advice. Additional Responsibilities Include: + Prepares device regulatory product strategies. Prepares and manages regulatory… more
- Bausch Health (Bothell, WA)
- …changes. Risk Management and Reporting + Conduct risk assessments related to regulatory compliance , helping the company identify potential non- compliance ... highlighting regulatory achievements and potential risks. Global Regulatory Compliance + Ensure compliance ...a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact… 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
- Bausch Health (Bothell, WA)
- …Bachelors Degree Required Life science or technical discipline preferred. Minimum 6 years regulatory experiences in MNC medical device company (aesthetic ... standards. + Work together with Bausch Health Group PRC regulatory lead, ensuring regulatory compliance ...a plus). Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR… more
- Fujifilm (Honolulu, HI)
- …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