Regulatory Affairs Jobs in Waltham (MA)
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Search Results - Regulatory Affairs Jobs in Waltham (MA)
CSL-Waltham (MA)-
with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’, appropriate inputs into risk assessment and decision making. Ensures bi-directional communication...
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Nova Biomedical-Waltham (MA)-
regulatory standards while enabling scalable growth across the organization.
The ideal candidate will be a collaborative leader who partners closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and Operations leadership to drive quality...
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Noema Pharma-Watertown (MA), 4 mi from Waltham (MA)-join.com-
using our novel therapies.
Tasks
The Director of Regulatory Affairs provides strategic and operational leadership to the development and commercialization of products for one or more of the Company’s clinical programs. Reporting to the SVP, Regulatory...
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Nova Biomedical-Waltham (MA)-
Contribute to the PMO knowledge base and template library.
• Maintain working fluency in FDA 21 CFR Part 11, ISO 13485, IEC 62304, and EU MDR as they apply to assigned projects. Partner with Regulatory Affairs and Quality on inspection readiness.
Experience...
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North Billerica, 13 mi from Waltham (MA)-icims.com-
be related to reported product failures.
• Other duties as assigned.
Qualifications:
• Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field required.
• A minimum of 4 years of direct Regulatory Affairs experience is required...
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Nova Biomedical-Waltham (MA)-
Nova Biomedical’s in-vitro diagnostic products are safe, effective, compliant, and built on robust design principles.
The Principal Design Quality Engineer I will partner closely with R&D, Systems Engineering, Regulatory Affairs, and Manufacturing...
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Reprieve Cardiovascular Inc-Milford (MA), 22 mi from Waltham (MA)-jobvertise.com-
the following:
At least eight (8) years of work experience in a regulatory affairs role or related occupation within the medical device industry.
Demonstrated knowledge of global market expansion beyond US/EU gained through eight (8) years of work experience...
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Bedford (MA), 6 mi from Waltham (MA)-icims.com-
and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Overview:
Job Summary
The Director of Regulatory Affairs, Post-Market Compliance...
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Climb Bio-Wellesley, 7 mi from Waltham (MA)-appcast.io-
Lead the clinical workstream of cross-functional study and program teams, partnering closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, CMC, Translational Sciences, and Program Management to deliver studies on time...
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Biopharma Careers-Boston, 10 mi from Waltham (MA)-appcast.io-
leadership teams, partnering with Clinical Development, Regulatory Affairs, Marketing, and Market Access and commercial
Provide oversight of rigorous scientific review and medical sign-off on all promotional, educational, and scientific materials via...
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