Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Manage and maintain regulatory databases and technical files. Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency req...
We have a robust pro Regulatory Affairs, Regulatory, Specialist, Principal, Product Development, Support, Business Services. ...
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...
Senior Compliance Risk Analyst. This role will support the overall privacy team and compliance initiatives by providing in-depth analysis, research, and coordination of projects, as assigned. Collaborates with various departments including IT, Risk Assurance and Marketing to ensure website processin...
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...
Food Safety Compliance Specialist to assist the Food Safety Manager with ensuring compliance with all food safety and sanitation laws and regulations in assigned store locations. The Food Safety Compliance Specialist’s goal is to maintain a food-safe and healthy environment for all customers, associ...
Project Manager – Power Delivery. These consulting services provide clients with overall project management tasks in the areas of comprehensive engineering design of electrical transmission and distribution, substation, and transmission line projects nationwide. Project Manager Responsibilities:. Pr...
We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. May act as a submission compliance liaison with other areas of Regulatory A...
This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufa...
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. Acts as a core team member on devel...
Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large. Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new...
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...
Individual Contributor responsible for QA Compliance Strategy for clinical and pre-commercial cell and gene therapies. Oversees contract manufacturing organizations (CMOs), monitoring information requests, reviewing CMO work, and following up on compliance-related items. Develops compliant Quality p...
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. Senior Regulatory Affairs Specialist #24-150 | Posted 07/24/2024 Marlborough, Massachusetts Ap...
Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships. Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on reg...
The Principal, Global Compliance Audit & Monitoring position reports directly to the Associate Director, Global Compliance Audit & Monitoring and is responsible for supporting program/project planning, execution, implementation, and reporting across a variety of Global Compliance programs. Obtain an...
The senior analyst will also draft, maintain, and communicate guidance documents on product compliance and other issues for target audiences, and review documentation for compliance with laws and regulations. Product Compliance Risk Analyst. They will work on projects relating to compliance with sta...
As we grow, we are seeking dedicated technical and professional individuals who want to collaborate on meaningful projects with a team that respects and values their ideas. ...
Authors, leads and manages all Quality/Regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the business strategy of the company are met. Leads and manages the development of all global regulatory communication proces...
The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Quality, Regulatory & Clinical Affairs strategy to support Waters business growth and success of the Clinical organization. Lead the Global Design Quality Assu...
Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders. Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working gr...
Review completed recertification to ensure program compliance Perform both onsite and remote audits to confirm compliance with program requirement through follow-up and closure Monitor waitlists, LAP plans and EIV master binders for compliance with federal and state regulations Review and submit res...
Our premier client is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs. Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alterna...
NPI Project ManagerAs the NPI Project Manager, you will manage all aspects of assigned project, from start to finish, so that it is completed on time and within budget focusing on NPI and small capital projects. Conduct project meetings and prepare reports to communicate the status of the project wi...
This member of the Quality Assurance team will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work clos...