This is an opportunity to join a global life sciences company in their medical devices division with complex devices and regulatory pathways. Coordinate, prepare, and execute regulatory documentation for the FDA including Premarket Notification 510(k), Pre-Sub, IDE, and PMA submissions in a timely m...
Title: Senior Regulatory Affairs Specialist. A leading global diagnostics company is seeking an experienced Senior Regulatory Affairs Specialist to join their ever-growing team. The Senior Regulatory Affairs Specialist will be responsible for:. Regulatory experience in the IVD space. ...
Principal Regulatory Affairs Specialist - Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and subm...
Principal Regulatory Affairs Specialist - Endoscopy. Principal Regulatory Affairs Specialist – Endoscopy . This role in Regulatory Affairs will be responsible fordeveloping regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contrac...
Regulatory Affairs Specialist (Level II or Senior Level). BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred. ...
The successful candidate will support regulatory activities at Yield10 Bioscience including drafting, securing, and submission of USDA-APHIS BRS permits and notifications for movement and release of regulated crop material, overseeing regulatory matters of field trials, and supporting other regulato...
In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations. The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technica...
In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations. The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technica...
Principal Regulatory Affairs Specialist – Endoscopy . This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and sub...
Our client is currently seeking a Senior Regulatory Compliance Specialist. Monitor international standards and guide regulatory testing requirements. Assist with risk analysis and regulatory submissions. ...
The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide. The ideal candidate is a diligent, hardworking individual with 2 to 5 years of regulatory expe...
The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory functions across POC's Portland & Gardner site...
Project Manager - Information Technology. Software/Infrastructure project experience. ...
Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documents. The Senior Director of Regulatory Affairs a...
As the Associate Director of Regulatory CMC, reporting to the Director of Regulatory CMC, you will be pivotal in managing the development and submission of regulatory filings for gene therapy projects both domestically and internationally. Identify and articulate regulatory opportunities and challen...
Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. Can apply and adapt this understanding to projects to enhance probability of regula...
Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC. The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for exe...
Analyze and review test packets, creating detailed test logs to track quality assurance. Oversee multiple projects concurrently, ensuring that quality standards are consistently achieved. Address quality issues promptly and develop effective solutions. Create or update procedures for capturing, inve...
The Quality Assurance Specialist will play a crucial role in supporting various areas within UGT Quality Assurance, ensuring compliance with Good Manufacturing Practices (GMP) and maintaining high standards of documentation. Our client is seeking a detail-oriented and knowledgeable Quality Assurance...
The Associate Director, Global Regulatory Science CMC Therapeutics Programs, will be responsible for leading regulatory CMC strategy and support for products in clinical development (IND, CTA) and commercial product registrations (BLA, MAA), including, post-approval variations. The Associate Direct...
Participate as a regulatory representative in relevant teams, advising on regulatory strategies, submission preparation timelines, processes, and requirements. Monitor and evaluate the US regulatory affairs environment to maintain awareness of current and future risks that may impact the business. C...
The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. The QA Compliance Specialist I performs quarterly audits...
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Lead the global Regulatory Affairs (RA) team and provide organizational guidance and support to Thermo Fisher Scientific's Laboratory Plastic Essential (LPE) business within the Laboratory Product Group (LPG). Reporting to the Senior Director of Regulatory Affairs, the incumbent will serve as a memb...
The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office. The Manager/Senior Manager will also participate to formulate regulatory CMC strategies for product developmen...