- Abbott (Maple Grove, MN)
- …managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a ... medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance,...- Regulatory Review + EU and US medical device compliance + Project management skills… more
- Abbott (Alameda, CA)
- …engineering, or medical fields. + 1+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of ... years' experience in a regulated industry (eg, medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and… more
- Sanofi Group (Cambridge, MA)
- …GRA Device representative in project/product teams + Develop innovative and sustainable medical device regulatory strategies + Provide regulatory ... quality , supply chain) and Global Business Units. Medical device technology is often exploring new...be key deliverables. **Knowledge:** + Proven experience in global medical devices regulatory for drug-led… more
- Cardinal Health (Mansfield, MA)
- …for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality , Regulatory & Medical Affairs (QRMA) Scientific Services. Under ... and data documentation. + Collaborate with cross-functional teams including Quality Assurance, and Regulatory Affairs and other...benefits and programs to support health and well-being. + Medical , dental and vision coverage + Paid time off… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices ...years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +… more
- Cardinal Health (Mansfield, MA)
- …for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality , Regulatory & Medical Affairs (QRMA) Scientific Services. Under ... experienced analytical chemist in Pharmaceutical Analysis Department, produces high quality data for pharmaceutical stability analyses. + Perform data compilation,… more
- Abbott (Alameda, CA)
- …5 years of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs + Medical device industry or other regulated environment ... are in place to meet global regulatory requirements. Provide metrics on medical events to support management of product quality issues. **What You'll Work… more
- Organon & Co. (Jersey City, NJ)
- …+ Participate on Organon teams supporting cGMP and quality issues related to pure medical devices and the device constituent of a combination product. + ... responsible for independent support of development and commercialization of Medical Devices including the device ... regulatory agency inspections with focus on relevant device regulations and Quality system requirements. +… more
- Medtronic (Santa Clara, CA)
- …field + 15+ years of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry **or** an advanced ... of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry. + 10+ years of people leadership,… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's ... Assurance group and reports to the Senior Manager, Medical Device External Quality . The...external product quality assurance (EPQA) for commercial medical devices which are manufactured by third… more
- Actalent (Piscataway, NJ)
- …degree discipline). + 4+ years of work experience in quality assurance and/or regulatory affairs in the medical device , biotech, life sciences, or ... Job Title: Quality Assurance and Regulatory Affairs SpecialistJob...industry. + Expertise and knowledge of clinical assays and/or medical devices in a regulated environment. +… more
- Cardinal Health (Mansfield, MA)
- …for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality , Regulatory & Medical Affairs (QRMA) Scientific Services. Under ... with analytical method verification and validation, and method transfer following regulatory guidelines, preferred + Experience with quality management systems… more
- Sanofi Group (Cambridge, MA)
- …will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of ... sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality...Relevant experience in risk management for medical devices . + Good knowledge of Quality System… more
- Cardinal Health (Mansfield, MA)
- …for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality , Regulatory & Medical Affairs (QRMA) Scientific Services. Under ... with analytical method verification and validation, and method transfer following regulatory guidelines, preferred + Experience with quality management systems… more
- Kelly Services (Dublin, CA)
- …between facilities. + Strong knowledge of regulatory requirements and quality standards for medical device manufacturing. **Important information:** ... + Engineering - Electrical or Mechanical preferable. + Medical Device experience in manufacturing: preferably electrical mechanical devices . + Transfer… more
- Abbott (Maple Grove, MN)
- …managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a ... (eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support,… more
- Wolters Kluwer (Chicago, IL)
- …portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... activities, including verification and validation. + Lead resolution of quality issues with on-market device software; drive... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices ... device , or pharmaceutical industry experience + Experience with both medical devices , drug- device combination products, digital health technologies… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …and 8 years experience in Quality , Regulatory , or Operations of a Medical Device firm in a supervisory role. + Professional certification is an advantage ... 13485:2016 + Knowledge of laws, regulations, standards and guidelines governing the sale of medical devices in Canada, the United States and Europe. + Ability… more
- Merck (West Point, PA)
- …Management Process, Manufacturing Methodologies, Materials Engineering, Mechanical Engineering, Medical Device Management, Medical Devices , Medical ... and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors,… more
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