| Job alert | Jobs 31 - 40 of 738 |
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
Senior Manager, Clinical Data Management
Takeda Pharmaceutical
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Lexington, MA, 02420
... Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions). Up to 20% travel required. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. ... - Jun 04
Regulatory Affairs Specialist II/Sr
Nova Biomedical
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Waltham, MA, 02454
... in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, IVDD, ISO 13485, quality system auditing. ... - May 18
Associate Director, Regulatory CMC
Intellia Therapeutics, Inc.
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Cambridge, MA, 02140
... Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA, and EMA guidelines. Meet your future team: The Global Regulatory Affairs group is a rapidly growing and ... - Jun 04
Director of Clinical Operations
Global Life Science Hub
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Boston, MA
... Strong understanding of FDA, EMA, and PDMA regulations and guidelines. Exceptional written and verbal communication skills. Strong ethical values and ability to build and lead high-performing teams. Apply: The Global Life Science Hub are a niche ... - Jun 01
Administrative Support- Massachusetts
Academy Solutions Group
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Winchester, MA
... Start date of June 26th, 2023 Winchester Engineering & Analytical Center: FDA requires a Full-time administrative service to support the initiative of electronic submission, notification and retention of ORA analytical worksheet records and perform ... - May 15
Clinical Program Manager
Allere
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Boston, MA
... Strong knowledge of FDA regulations and willing to learn foreign regulatory requirements Proficient in Microsoft Office (excel, word, outlook, power point), electronic data capture (EDC) Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and ... - Jun 01
Director Regulatory Strategy
Meet
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Cambridge, MA, 02140
... This position offers the chance to influence and drive regulatory strategies that align with our cutting-edge oncology assets, fostering collaboration with the FDA to expedite the development and approval of new therapies. Key Responsibilities: ... - May 26