| Resume alert | Resumes 41 - 50 of 461 |
Document Reviewer Team Member
Billerica, MA
... ● Technical lead - biomarker IHC assay projects, submitted to FDA (immuno-drug conjugate assays) in support of Phase I/II clinical trials ● Wrote standard work, assay development procedures, final GLP reports. ● Authored portions of IND submissions, ... - 2023 Jun 07
... ● Technical lead - biomarker IHC assay projects, submitted to FDA (immuno-drug conjugate assays) in support of Phase I/II clinical trials ● Wrote standard work, assay development procedures, final GLP reports. ● Authored portions of IND submissions, ... - 2023 Jun 07
Safety Specialist Regulatory Affairs
Boston, MA
... I worked for QA, gap analysis, and validation, with a strong focus on ensuring compliance with FDA regulations. I am now seeking a role as a Regulatory Affairs Associate in the biotechnology and medical device industries where I can leverage my ... - 2023 Jun 01
... I worked for QA, gap analysis, and validation, with a strong focus on ensuring compliance with FDA regulations. I am now seeking a role as a Regulatory Affairs Associate in the biotechnology and medical device industries where I can leverage my ... - 2023 Jun 01
Regulatory Affairs Quality Supervisor
Malden, MA
... Studies, Boston, USA Jan 2021 – Dec 2022 MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices Relevant Coursework: FDA Pharmaceutical and Medical Device Regulations, Pharmaceutical Engineering, Pharmaceutical and Medical Device Law, ... - 2023 Apr 17
... Studies, Boston, USA Jan 2021 – Dec 2022 MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices Relevant Coursework: FDA Pharmaceutical and Medical Device Regulations, Pharmaceutical Engineering, Pharmaceutical and Medical Device Law, ... - 2023 Apr 17
Scrum Master Quality Engineer
Andover, MA
... Hardware and Software Design > 12 years Medical Devices > 10 years Cyber Security / PKI >5 years ISO 9001 > 10 years FDA 21 CFR Part 11, 210, 211, 820, HIPPA, ISO 9001 >5 years IEC 62304, IEC 82304, ISO 13485, EU Annex 11, EU MDR > 5 years AS9100 D. ... - 2023 Apr 14
... Hardware and Software Design > 12 years Medical Devices > 10 years Cyber Security / PKI >5 years ISO 9001 > 10 years FDA 21 CFR Part 11, 210, 211, 820, HIPPA, ISO 9001 >5 years IEC 62304, IEC 82304, ISO 13485, EU Annex 11, EU MDR > 5 years AS9100 D. ... - 2023 Apr 14
Regulatory Affairs Intern
Boston, MA
... of eCTD Submission, Human Experimentation, Therapeutic Product Development, Regulatory Compliance and Practice, Introduction to FDA Pharma Regulation, Advertising and Promotional labelling, Pharma and Medical Device Law Jawaharlal Nehru Technology ... - 2023 Apr 05
... of eCTD Submission, Human Experimentation, Therapeutic Product Development, Regulatory Compliance and Practice, Introduction to FDA Pharma Regulation, Advertising and Promotional labelling, Pharma and Medical Device Law Jawaharlal Nehru Technology ... - 2023 Apr 05
Cinical Research Associate
Boston, MA, 02108
... s information into database and analyze research questionnaires/Graphs Maintained case files according to department, study, FDA requirements and working knowledge of ICH- GCP Reviewed safety study files for extraneous documents and to ensure ... - 2023 Mar 24
... s information into database and analyze research questionnaires/Graphs Maintained case files according to department, study, FDA requirements and working knowledge of ICH- GCP Reviewed safety study files for extraneous documents and to ensure ... - 2023 Mar 24
Service Representative Customer
Revere, MA
... Relations ● ● Patients Advocacy ● Microsoft office ● Patient Confidentiality ● Staff Development ● Problem-Solving Skills FDA and HIPAA Compliance ● Children's Developmental Clinic PHARMACY INTERN 06/2022 to 07/2022 Partners Pharmacy, Marlborough, ... - 2023 Mar 20
... Relations ● ● Patients Advocacy ● Microsoft office ● Patient Confidentiality ● Staff Development ● Problem-Solving Skills FDA and HIPAA Compliance ● Children's Developmental Clinic PHARMACY INTERN 06/2022 to 07/2022 Partners Pharmacy, Marlborough, ... - 2023 Mar 20
Mechanical Assembler Tester
Lowell, MA
... Following BOM’S and Assembly Drawings to ensure all ECO activity is captured in an FDA controlled business. Knowledge of loading software, powering up systems, the use of adhesives in applying heat sinks to PCB’S, and PLC’s. Perform technical tasks ... - 2023 Mar 15
... Following BOM’S and Assembly Drawings to ensure all ECO activity is captured in an FDA controlled business. Knowledge of loading software, powering up systems, the use of adhesives in applying heat sinks to PCB’S, and PLC’s. Perform technical tasks ... - 2023 Mar 15
Clinical Research Coordinator
Boston, MA
... Processed study documentation for compliance with FDA, site visits, agreements, and certifications/training of the study staff in accordance with study-specific TMF Plans and other applicable guidelines. Performed quality review of documents of the ... - 2023 Mar 03
... Processed study documentation for compliance with FDA, site visits, agreements, and certifications/training of the study staff in accordance with study-specific TMF Plans and other applicable guidelines. Performed quality review of documents of the ... - 2023 Mar 03
Regulatory Affairs Chemist
Lowell, MA
... TECHNICAL SKILL Medical Device: 510(k), IDE, PMA, UDI, MDRs, ISO 13485, ISO 14971, DMR, DHR, DMF Drugs and Biologics: pre-IND, IND, DMF, NDA, BLA, MAA, ANDA, Regulatory Submissions Compliance Audits: FDA Form 483, Warning Letters, Consent Decrees, ... - 2023 Feb 27
... TECHNICAL SKILL Medical Device: 510(k), IDE, PMA, UDI, MDRs, ISO 13485, ISO 14971, DMR, DHR, DMF Drugs and Biologics: pre-IND, IND, DMF, NDA, BLA, MAA, ANDA, Regulatory Submissions Compliance Audits: FDA Form 483, Warning Letters, Consent Decrees, ... - 2023 Feb 27