- Chemours (Boston, MA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… 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
- Cognizant (Chicago, IL)
- …discovery, Global Pharmaceutical market and industry, including BioTech, Medical Device , Traditional Rx, enabling technologies and regulatory / compliance ... **Experience Partner - Life Sciences (Pharma / BioTech / Medical Device )** **Associate Director - Chicago/Midwest Remote** **Who we are:** We are Cognizant… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +...detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems +… 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
- 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
- Wolters Kluwer (Chicago, IL)
- …the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...subject matter expert. + Assure integration and support of device regulations and compliance with company policies… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... mindset and drives a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards. This critical...regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's External and ... Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role… more
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