| Job alert | Jobs 1 - 10 of 762 |
Head of Regulatory Affairs
Thymmune Therapeutics
–
Cambridge, MA, 02142
... This role involves extensive interaction with regulatory agencies, especially with the FDA, seeking scientific advice and approvals, and provides cross-functional leadership for filings, ensuring compliance with local regulatory requirements and ... - Sep 28
Senior Scientist: IVD Assay Developer
Nanobiosym
–
Cambridge, MA, 02142
... DUTIES Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission Manage and contribute to regulatory documents Project management; personnel management skills preferred Design assay performance specifications ... - Sep 27
Regulatory Affairs Co-Op/Intern
Nova Biomedical
–
Waltham, MA, 02454
... The RA Intern will provide pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. Other responsibilities include: Support Self-Certified and Notified Body ... - Sep 18
Associate Director, Quality Operations (Biologics)
Jobot
–
Boston, MA
160000USD - 190000USD per year
... ICH guidance, FDA/EMEA GMP regulations, etc.) for manufacturing, testing, packaging and distributing drug substances and drug products Direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus Demonstrated ... - Sep 28
Health Care Associate
5 Legal
–
Boston, MA
... Candidates should have a minimum of 3 years of relevant experience and possess expertise in those aspects of health regulatory law applicable to the health care and life sciences industries including FDA regulatory matters, clinical research, and ... - Sep 27
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 ... - Sep 28
Clinical Research Coordinator
Alcanza Clinical Research
–
Roslindale, MA
... 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 regulations and guidelines. ... - Sep 27
Account Executive, Point of Care - New England
Nova Biomedical
–
Boston, MA, 02111
... Product portfolio includes Nova’s StatStrip – Only glucose meters accurate enough to be FDA-cleared for use with all patients, including critically ill. We offer competitive base salary, uncapped commission, company car and many other comprehensive ... - Sep 17
Drug Safety Physician
Dragonfly Therapeutics
–
Waltham, MA
... This individual will ensure timely, consistent and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs). Responsibilities ... - Sep 14
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. ... - Sep 27