- Moffat Workforce (Plymouth, MN)
- …1 or more years of Inspection experience in a medical device environment. Some experience using associated measurement devices (microscope, caliper, laser ... (AX). Participate in external audits advocating the company (Customer, 3rd party, Regulatory ). Other activities and responsibilities as assigned. Quality Control… more
- Sally Beauty Holdings (Argyle, TX)
- …with Tax Department /Distribution Centers to obtain licenses for OTC products, medical devices , and dietary supplements, etc. Knowledge, Sklls and Abilities: ... in YOU. Join us." Primary Duties: Ensure product safety, quality and regulatory compliance of Private label...a competitive salary and outstanding benefits package that includes medical , dental, vision, life Insurance, paid vacation and sick… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …is currently admitted to practice in that jurisdiction. + 8+ years of relevant medical device regulatory law experience + Ability to effectively communicate ... and other regulatory issues specifically related to medical devices and/or diagnostics throughout the lifecycle...home-use medical devices , and durable medical equipment + Experience supporting RA and Quality… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …experience in FDA and other regulatory issues specifically related to medical devices and/or diagnostics throughout the lifecycle of the product, including ... will serve as a strategic legal partner to BD's Regulatory , Quality , Medical Affairs, Sales...navigate controversial situations and negotiations + Deep understanding of regulatory requirements for connected device solutions, including… more
- Kelly Services (Bridgewater, NJ)
- …for new/updated departmental procedures and processes. + Liaise with internal functions ( Quality , Regulatory , Medical Affairs, Clinical) to gather critical ... **EU- Medical Device Regulation (MDR) Specialist** Kelly(R) Science & Clinical is seeking an **EU-MDR Specialist** for our client in Bridgewater, NJ. If you're… more
- AbbVie (Irvine, CA)
- …and strategy (eg, Pharma and Medical Device Regulation) for medical products to support global regulatory plans. + Coordinates across the Allergan ... as applicable. In addition, the incumbent is the key regulatory contact for Quality , Medical ...scientific discipline is highly desirable. + 8 years of regulatory experience in the medical device… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …in a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC; international ... and meetings with global health authorities + Reviews and approves medical device development design control documentation, including technology transfer… more
- Actalent (Jacksonville, FL)
- …environment and maintain positive communications and collaborations. Hard Skills + Medical Device Regulatory Affairs + Quality Assurance + GMP Medical ... Job Title: Regulatory Affairs Specialist Job Description We are seeking an experienced Regulatory Affairs Specialist to head their own projects and submit… more
- Abbott (Santa Clara, CA)
- …with diabetes from routine fingersticks. We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....or Plano, TX. This position is included in the ** Medical Device Regulatory Affairs Development… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience ... landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards,...with stakeholders in HA and in industry for US regulatory activities for devices and combination products… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …during the development process to ensure submission acceptance and approval + Manages the device regulatory strategy of high quality and compliant ... the highest level of ethical standards + Creates high quality , compliant regulatory device documents...8+ years of biotechnology, pharmaceutical or medical device industry experience + 5+ years of regulatory… more
- Meta (Seattle, WA)
- …software as a medical device (SaMD). **Required Skills:** Head of Medical Devices Regulatory Affairs Responsibilities: 1. Lead project teams for ... **Summary:** Reality Labs is seeking an experienced medical devices regulatory affairs...product approvals for novel hardware and software as a medical device products for distribution into many… more
- Bristol Myers Squibb (Princeton, NJ)
- … medical devices & combination products by drawing on experience w/ medical device quality system regulations, including ISO 13485, 21CFR 820, 21CFR ... regulatory submission timelines. Collaborate w/ the manufacturing sites, device quality group, & product quality... Quality Database & Global Safety System for medical devices & combination product complaint records… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …between departments, CMOs and sites respective to Combination Drug Products and Medical Devices . This position performs the function of Independent Reviewer ... for troubleshooting and problem solving that pertain to Combination Product and Medical Devices . + Establish product specific electronic folders, organize and… more
- Bausch + Lomb (Rochester, NY)
- … medical terms, medical device reporting regulations, GMPs for medical devices . **We offer competitive salary & excellent benefits including:** + ... management for critical and/or unusual events. + Liaises with internal functions ( Quality , Regulatory , Medical Affairs, Customer Service, Manufacturing and… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... quality management system in support of AbbVie medical devices and combination products. The role...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- AbbVie (Irvine, CA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... quality management system in support of AbbVie medical devices and combination products. The role...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- Merck (Wilson, NC)
- …products. + Experience with injection molding and working with medical device suppliers. + Experience leading Quality Management System gap assessments ... MDCP Operations Lead position will serve as the primary medical device and combination product (MDCP) point...develop and apply value-add solutions to customer needs in medical devices and combination products. + Provide… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory ...and regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more
- Bausch + Lomb (Clearwater, FL)
- …medical terms, medical device reporting regulations, GMPs for medical devices preferred. + Position requires strong written, oral and listening ... management for critical and/or unusual events. + Liaises with internal functions ( Quality , Regulatory , Medical Affairs, Customer Service, Manufacturing and… more
