| Job alert | Jobs 21 - 30 of 845 |
Senior Manager, QA Auditing
Sarepta Therapeutics
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Andover, MA
... Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations. Understanding of GMP/GDP ... - May 29
LPN Dispensing Nurse
Lowell Comprehensive Treatment Center
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Lowell, MA
... Responsible for the safekeeping of all medication stock and the records required by the DEA, FDA, and ADP; Dedicates a minimum of 90% of regularly scheduled work hours to activities directly related to the administration of medication; the remaining ... - May 16
Senior Product Security Engineer / Biotech / Danvers, MA
Motion Recruitment
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Danvers, MA, 01923
... Hands on experience with threat models and security designs Familiarity with relevant regulations and standards, such as HIPAA, FDA guidelines, and ISO 27001 Desired Skills & Experience Bachelor's or Master's degree in Computer Science, Information ... - May 16
QC Inspector
Finish Line Staffing Services
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Wilmington, MA
... Diploma, GED, or equivalent work experience 3+ years of experience performing inspection within an FDA or other regulated environment DCO generation Proficient in the use of hand measuring tools such as calipers, micrometers, dial indicators, etc. ... - May 09
Associate Director, Global Regulatory Strategy, Infectious Disease
Moderna Therapeutics
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Cambridge, MA
... Leads the development of content, format and accountability for regulatory submissions and related supplements and amendments to at least the US FDA, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric ... - May 26
Plant Director
Diversified Recruitment Services, LLC
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Wilmington, MA, 01887
... Strategic planning for annual plans to ensure that the business complies with ISO, FDA, EPA, OSHA and all other legal requirements. Drive rapid, significant and sustainable improvement in SQDC Provide the leadership necessary for the development and ... - May 19
Manager, Regulatory Affairs - IV Therapy
Fresenius Kabi USA, LLC
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North Andover, MA, 01845
... Experience in authoring infusion system applications to FDA is highly preferred (e.g., pre-subs, 510(k)s, IDEs) Sound regulatory and scientific knowledge Experience and proven effective collaboration in a multicultural environment Strong oral and ... - May 26
Document Control Specialist
Deephealth
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Somerville, MA
... Minimum Qualifications, Education and Experience Associate’s degree in relevant field (or equivalent experience) 2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred) as a document control specialist Experience ... - May 30
Medical Device - Regulatory Affairs and Quality Assurance Manager
Cambridge Interventional
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Burlington, MA, 01805
... · Responsible for the development and implementation of ISO 13485 requirements, including internal GMP/ FDA QSR audits. · Prepare and submit device regulatory submissions including EU MDR and 510(k) applications. · Responsible for regulatory ... - May 30
Sr. Group Leader, PCB Manufacturing
Nova Biomedical
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Waltham, MA, 02454
... FDA requirements a plus. Working knowledge of inventory control practices and manufacturing planning. SAP ERP experience a plus. Working knowledge of SMT PCB equipment, SMT assembly and processes including BGAs. Skills and Competencies: Ability to ... - May 08