- DivIHN Integration Inc (Atlanta, GA)
- …so 2-5 years of experience is acceptable. Industry experience, medical device Background in Electro-Mechanical devices are flexible Regulatory experience is ... inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic… more
- DivIHN Integration Inc (Woodland, CA)
- …Years and Area of Experience: Minimum 3 years' experience in Quality or Regulatory , preferably in a medical device , pharmaceutical or biotechnology ... of Position: Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality… more
- DivIHN Integration Inc (Hayward, CA)
- …Bachelor's degree in relevant discipline or equivalent experience Experience with applicable medical device (21CFR820, ISO 13485, CMDR, MDD) and/or biologics ... of in-process and finished goods documentation to verify compliance to SOPs and regulatory requirement. Write, revise and review SOPs. Perform QA on the floor… more
- Fisher Associates (Syracuse, NY)
- …but not limited to, the decision to use or access a particular drug, device , or medical service), marital status, partnership status, caregiver status, domestic ... Environmental Regulatory Specialist Syracuse, NY (http://maps.google.com/maps?q=120+East+Washington+St.+Syracuse+NY+USA+13202) * Environmental Job Type Full-time… more
- Food and Drug Administration (Silver Spring, MD)
- …Office of Blood Research and Review (OBRR) which serves as a Regulatory Health Project Manager, responsible for the planning, facilitating, and coordinating of ... meetings. Reviews applications to ensure compliance with all legal, regulatory and policy requirements. Tracks each submission/application being managed while… more
- Guidehouse (Mclean, VA)
- …Life Sciences practice is an engine of innovation helping pharmaceutical, biotech, medical device , and diagnostic regulators tackle today's challenges, while ... **Job Family** **:** Strategy & Transformation Consulting **Travel Required** **:** Up to 10% **Clearance...We are looking for someone who brings industry and/or regulatory knowledge, strategic planning experience, and a passion for… more
- Publicis Groupe (New York, NY)
- …Saatchi & Saatchi Wellness has provided consumer and professional marketing, strategic consulting , and medical education to pharmaceutical and wellness brands. ... submissions follow the protocols established by our pharmaceutical and medical /surgical device clients for promotional materials. This...PM and Account teams as they prepare projects for Medical Legal Regulatory (MLR) review + Submit… more
- Penn Medicine (Philadelphia, PA)
- …and high risk equipment, utilizing a strong understanding of medical device integration and networking. + Participates in regulatory readiness and manages ... tasks that have been mastered. + Uses understanding of Regulatory and Safety requirements to communicate Biomed compliance to...and high risk equipment, utilizing a strong understanding of medical device integration and networking. + Correctly… more
- University of Rochester (Rochester, NY)
- …Initiatives, continually modify, as necessary, current quality systems to comply with the Medical Device regulation (21 CFR Part 820) and the European Commission ... direct and oversee implementation and ongoing compliance with the Medical Device Regulations through the establishment of...+ At least 8 years of Quality Assurance and/or Regulatory experience in the pharmaceutical or device … more
- ICU Medical (UT)
- …different areas such as Medical Device Implementation, Quality, Medical , Commercial, Manufacturing Operations, Regulatory is preferred but not required. ... experience with MS Office, including MS Project.** . Experience in managing medical device implementations is required.** *Education and Experience* . Bachelor's… more
- Guidehouse (New York, NY)
- …Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device , and diagnostic companies develop custom solutions that tackle ... value, access, pricing and commercialization strategy projects for pharmaceutical, biotechnology, medical device , and diagnostics companies. Our client services… more
- ThermoFisher Scientific (Wilmington, NC)
- …(especially peri- or post-approval late phase interventional studies) Medical device development (in-vitro diagnostics, SaaMD) Post-authorization ... winning project work related to pregnancy and lactation studies through scientific consulting . Understand the regulatory context for RWE specifically related to… more
- Lilly (Indianapolis, IN)
- …multidisciplinary team leadership; to work with colleagues from design, engineering, medical , marketing, quality, manufacturing and regulatory to apply ... experience, and digital user experience are all considered during device development. + Oversee and contribute to analytic human...ensures compliance to relevant standards and FDA and OUS regulatory and human factors guidance for medical … more
- Microsoft Corporation (Mountain View, CA)
- …and Access Management Control platforms such as Entra, Cloud security and regulatory compliance standards, Endpoint device and application controls such as ... **Required Qualifications** + 7+ years technical pre-sales or technical consulting experience + OR Bachelor's Degree in Computer Science, Information… more
- Abbott (Abbott Park, IL)
- … regulatory requirements. Work effectively with multiple different divisions and medical device technologies. Relies on extensive experience and judgment to ... ideal. + Minimum 10 years in Progressive work experience in software related medical device or high technology industries. Minimum 10 years prior management… more
- Precise Solutions (Lake County, IL)
- …Description: Primarily responsible for representing QA on cross-functional Software as a medical device (SaMD) and Digital Health Software product development ... ensure products are developed, tested, and released in compliance with worldwide Medical Device Regulations. Responsible for authoring, reviewing, and approving… more
- AbbVie (North Chicago, IL)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …microbiological liaison, data analytics, epidemiological investigative principles, medical device /technology product evaluation, performance improvement, ... prevention experience with patient safety, including hospitals, academia, health systems, medical device and/or pharmaceutical manufacturers. + Domestic and… more
- Medtronic (Detroit, MI)
- …M&T Structural Heart Business is one of the fastest growing businesses in the medical device industry and expanding rapidly to serve patients globally. The ... drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion...be assigned. + Conducts on-site education and / or consulting . + Supports field personnel in providing the best… more
- KPMG (Short Hills, NJ)
- …+ Minimum ten to fifteen years of Regulatory experience in the Medical device , consulting and/or business experience or combination thereof in ... the Quality domain within the Life Science industry (Pharmaceutical, Medical Device , BioTech and Clinical Research Organization) + Bachelors degree from an… more
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