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 ...
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...
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...
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...
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 and perform regulatory submissions, product registrations/listings and renewals towards FDA, Health Canada and other Regulator...
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...
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...
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...
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 and perform regulatory submissions, product registrations/listings and renewals towards FDA, Health Canada and other Regulator...
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 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...
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...
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...
We are looking for an experienced Biomarker Operations Project Manager to join our North America team!. This is a remote position and will be project management and computer-based. Partner with cross-functional teams to ensure timely achievement of clinical and project related objectives. Accurately...
GMP environment, including 5 years project management experience with demonstrated success leading projects. Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified. Understand and manage deliverab...
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...
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...
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...
Quality Engineer who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP reg...
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...
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 Environmental Project Manager will manage all aspects of environmental investigation, remediation, O&M, and LTM projects for our Federal customers. Oversee project financials including project budgets, cost control performance, profitability updates to managers, labor costs and expenses, tra...
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...
Regulatory Affairs Leader (Associate Director). Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience. The Regulator...