The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technical documentation and conduct other elements of sustaining Regulatory Affairs including maintaining “state of the art”. In addition, this position will support the regulatory department by maintaining data within reg...
Regulatory Affairs (RA) Specialist?. Regulatory Affairs (RA) Specialist who wants to grow your skills and take the lead on U. You will report to the SVP, Global QA, RA & ESG and work closely with colleagues from R&D, Product Management & Marketing, QA&RA and other functions, to plan ...
The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technical documentation and conduct other elements of sustaining Regulatory Affairs including maintaining “state of the art”. In addition, this position will support the regulatory department by maintaining data within reg...
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. Regulatory affairs experience in generating applications and experience in collaboration with ...
Do you have a Project Management background and an interest in Operational Technology (OT), Control Systems, or cyber? Have you learned about or worked with OT/Control Systems and have an interest in business and project management? The Cyber Infrastructure Protection Innovation Center is seeking a ...
They are seeking a dynamic Director of Regulatory Strategy to steer our groundbreaking projects through the complex regulatory landscape with vision and precision. Director, Regulatory Strategy. Bachelor's degree in a relevant life sciences field with at least 8 years of experience in the biopharmac...
Regulatory Affairs Certification (RAC) or equivalent preferred. Ensure that all products and processes comply with applicable regulatory requirements (e. Prepare and submit regulatory documentation and applications, including product registrations, certifications, and renewals. ...
They are looking to add a Regulatory lead to head up the EU side of the Regulatory department. Senior Director of Regulatory Affairs - Responsibilities:. Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance a...
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...
Architectural Project Manager - Worcester, MA. Architectural Project Manager (PM) for our Worcester, MA office location. We seek a licensed architect with 10 + years’ experience in the management of architectural projects for educational, commercial and/or institutional projects and who is directly ...
Kirby Bates Associates, a national healthcare leadership firm, has an engagement opportunity for an Interim Manager/ Documentation Regulatory Specialist in Massachusetts at a residential and LTC facility. The leader must be able assist at the unit levels with hands-on monitoring and mentoring and ha...
The Senior Project Manager will serve as a consultant for the duration of the project, which is expected to run from September to March. Project Management Certification (PMP) - Project Management Institute (PMI) - upon hire – Preferred. Advanced knowledge of Project Management Body of Knowledge gui...
As a Trade Compliance Analyst, you will play a key role in ensuring our company's compliance with global customs authorities and facilitating day-to-day trade compliance activities. Are you an enthusiastic professional looking to expand your experience or start a career in Trade and Compliance? Rand...
Today, guided by our mission of improving health and inspiring hope, we strive to be the leading provider of government-sponsored health insurance programs—including Medicare, Medicaid, and PACE (Program of All-Inclusive Care for the Elderly)— in the region. Fully understands and keeps abreast of ch...
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...
Experienced with the preparation and submission of regulatory documents, including PIND meeting packages, INDs, NDAs, ANDAs, regulatory correspondence, and amendments. Well established European pharmaceutical firm that supports the pharmaceutical industry with Intermediates, API's, Drug Products and...
Who you are - Commercial Compliance Analyst. Represent the Compliance Team, as needed, by actively participating in Institutional Projects and communicating follow up items, compliance considerations, and areas of concern back to the team. As a member of our Compliance Department, you will join a dy...
Global Project Manager will manage large capital projects from project initiation through execution and closeout. The Project Manager will identify and develop the project requirements and then develop the project scope and plan to meet those requirements. Lead cross-functional teams, applying proje...
Manages small projects such as equipment upgrades and roll outs. Assists with other projects as assigned. Manage small projects as assigned. ...
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...
This Compliance Specialist 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 closely with talent...
Collaborates with other functional work teams , 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 projec...
Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties. Significant regulatory affairs experience is required. Provides stra...
What is the Compliance Analyst responsible for?. Create summary reports to Compliance and Business Management that detail compliance findings and corrective actions. What is the Compliance group responsible for?. Franklin Templeton’s Global Compliance team provides oversight and guidance to the vari...
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...