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Job alert Jobs 31 - 40 of 995

Senior Compliance Auditor

Planet Professional  –  Cambridge, MA, 02140
... Knowledge of relevant FDA regulations/guidance and ICH Guidelines. Ability to plan/execute and report audits independently. Experience in cell manufacturing/biologics, medical devices, and/or software quality. Exposure to Good Clinical Practice (GCP ... - May 11

Associate Director Clinical Operations

Meet  –  Boston, MA, 02298
... Strong understanding of GCP guidelines, FDA regulations, and other relevant regulatory requirements. Excellent communication, leadership, and problem-solving skills, with the ability to work effectively in cross-functional teams. - May 17

Director of Clinical Operations

Global Life Science Hub  –  Boston, MA, 02298
... 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 ... - May 16

Sr. Clinical Trial Manager

Meet  –  Boston, MA, 02298
... Strong understanding of GCP guidelines, FDA regulations, and other relevant regulatory requirements. Excellent communication, leadership, and problem-solving skills, with the ability to work effectively in cross-functional teams. - May 17

Senior Supplier Quality Engineer

InfraredX, Inc.  –  Bedford, MA, 01730
... Maintains supplier quality records in accordance with FDA/GMP and EU MDR requirements. Coordinate review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval. Assist with ... - May 17

Sr. Group Leader, PCB Manufacturing

Nova Biomedical  –  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

Clinical Research Coordinator

Alcanza Clinical Research  –  Roslindale, MA
... The Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH ... - May 18

Quality Control Manager

North Coast Seafoods  –  Boston, MA
... root cause analysis and corrective action Plan, prepare and participate in all audits including: organic, kosher, customer, FDA, internal and 3rd party Sustain and improve ratings on annual certifications Performs other related duties as assigned ... - May 03

Senior Director Regulatory Affairs

EPM Scientific  –  Boston, MA, 02298
... 5 years of direct experience in regulatory strategy Experience in autoimmune disease Proven success with regulatory submissions such as IND, CTA, MAA, NDA, BLA Vast knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs and other international ... - May 13

Regulatory Affairs Specialist II/Sr

Nova Biomedical  –  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
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