Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...
Senior Manager of Regulatory Affairs and Quality Assurance - (Medical Device) - Hybrid in MA. Our client is a growing boutique IVD and Medical Device company and they are seeking a Senior Manager of Regulatory Affairs and Quality Assurance to lead a small international team to ensure compliance with...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Collaborates with other functional work teams , Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of glob...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
The newly founded LGBTQ Health Center of Excellence seeks a highly motivated individual to join the organization in the Senior Program Manager role to serve as the Executive Director. From academic faculty and trainees to research/program staff and administrative professionals, no matter the positio...
This person will report to the Senior Project Manager (SPM) and the Director of Project Management. Onboard new projects with the Senior Project Manager and Property Management Team. Work closely with Senior Project Manager to prepare bid packages for projects. CHARLESGATE seeks a dynamic Project Ma...
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...
Director of Capital Facilities or their designee, the Senior Project Manager - Architectural facilitates and leads capital improvement and/or infrastructure projects from conceptualization and functional space planning to design development, project approval and implementation and ensures that all p...
We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. Associate / Consultant will also provid...
The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. Conceive of and Implement the Regulatory Strategy in ...
The Construction Project Manager will oversee a variety of building envelope and light commercial construction projects. The Construction Project Manager ensures that all projects comply with building codes and governing authorities' requirements. The role involves maintaining project goals, sch...
Actively communicate project updates and any necessary project risk mitigation to clients, including changes to project scope, schedule and/or costs as necessary. The Enterprise Project Manager actively facilitates client engagements, manages client deliverables to completion and focuses on supporti...
QUALITY AND COMPLIANCE MANAGER. The Quality and Compliance Manager will be focused on:. Experience with compliance standards; REACH, RoHS. Collaboration with Global Quality Team and Supply Quality leads and working close with Value Stream Managers advising on Quality matters to achieve zero defect a...
A Program Manager overseeing the implementation of a grant focused on refugee and immigrant maternity care would have a variety of responsibilities to ensure the program's success. The Project Manager for the Maternity Care program will help implement a state grant focusing on improving maternal...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
Sustainability Program Manager. Sustainability Program Manager - North America Region. Entegris is seeking an experienced Corporate Sustainability Program Manager - North America. Lead the Life Cycle Analysis Program to assess the environmental impacts associated with all stages of a product or proc...
The Ethics & Compliance Manager Position reports directly to the Ethics and Compliance Director, who reports to the VP of Enterprise Risk Management & Compliance (including Data Privacy and Protection). This individual will support the development, implementation, and maintenance of the Operational ...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
Principal Regulatory Affairs Specialist - EndoscopyAbout the role:At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new busine...
Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertPrincipal Regulatory Affairs Specialist - Endoscopy Onsite Location(s): Marlborough, MA, US, 01752Additional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - Hi...
Job DescriptionJob Summary:The Licensing Analyst, Trade Compliance (TC) works with internal stakeholders to assess international business requirements, prepare export license applications, apply appropriate use of license exemptions when available, and assist business partners to navigate export app...