Fda Jobs in New York (NOW HIRING)

TITLE: FDA ATTORNEY POSITIION: DIRECT HIRE Firm X, established in 2000, is a national boutique law firm focused exclusively on Healthcare and Life Sciences. The Firm draws on its experience ...

The firm maintains a highly active FDA practice and receives an average of approximately five new FDA-related client inquiries each week. The successful candidate will inherit access to a strong ...

Turing invites Healthcare and FDA Regulatory Law experts to join projects that fine-tune AI models like ChatGPT. You will apply your expertise in healthcare compliance, FDA drug/device approval, Anti ...

Selected experts will assess whether clinical and regulatory materials meet FDA evidentiary and formatting expectations, identify deliberately embedded deficiencies, and develop authoritative ...

Selected experts will assess whether clinical and regulatory materials meet FDA evidentiary and formatting expectations, identify deliberately embedded deficiencies, and develop authoritative ...

Lead preparation and submission of FDA 510(k) applications. * Coordinate CROs and external consultants. * Prepare DHF, risk management, clinical studies, labeling, and technical files. * Serve as ...

The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely ...

The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely ...

The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely ...

The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely ...

S. FDA regulations and current guidance documents. Working in close collaboration with the Director of Regulatory Affairs, the Regulatory Affairs Manager serves as the Regulatory CMC lead for ...

S. FDA regulations and current guidance documents. Working in close collaboration with the Director of Regulatory Affairs, the Regulatory Affairs Manager serves as the Regulatory CMC lead for ...

Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Candidate will be required to work ...

Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission ...

Strong working knowledge of FDA guidance documents and eStar requirements. * Experience with Canadian regulations, EU MDR (2017/745) including Class IIa, Tech docs Annex II/III. * Demonstrated ...

Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) at one of eight Human and Animal Food Laboratory locations across the United States. This position plays a key ...

Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) at one of eight Human and Animal Food Laboratory locations across the United States. This position plays a key ...

Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) at one of eight Human and Animal Food Laboratory locations across the United States. This position plays a key ...

Liaise with FDA OPDP on advertising/promotion matters, including advisory submissions. * Ensure compliance with promotional submissions to FDA on Form 2253. * Monitor evolving regulatory requirements ...

Ensure manufacturing/packaging comply with cGMP, FDA regulations, approved procedures, batch records, and internal quality standards. * Review production, packaging, and quality documentation for ...