A company is looking for an Associate Director / Director, Global Regulatory Affairs for a remote position. ...
The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs. Respo...
A company is looking for a Regulatory Affairs Director. ...
Regulatory Affairs Manager, CMC. The Regulatory Affairs professional we seek is a leader with these qualifications. Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality...
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environment...
The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval. In collaboration with the V...
Regulatory Affairs Specialist & Quality Assurance Specialists -. Maintain, update and track regulatory requests - provide periodic status updates to open and closed requests. Maintain regulatory files for product compliance. ...
This person will be a key member of Regulatory Affairs project teams to accomplish tasks that are instrumental to the company’s success. Work closely with Regulatory Strategy Leads, Medical Writers, and Regulatory Document Specialists to execute project plans;. Attend clinical operations internal me...
Collaborate with cross functional partners to anticipate, communicate and resolve/mitigate risks or issues• Monitor the regulatory environment and watch for trends in local and international spheres for the product category and topic area that you own to assess impact on our products and business; i...
Duties focus on regulatory affairs. Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or bachelor's degree and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs. Clinical Re...
Serves as the principal regulatory contact point and manage consultants, attorneys, lobbyists and interact with regulatory contacts at both Federal and State Commissions, local authorities, utilities, RTOs, energy coalition groups and other competitive retailers and as such frequently respond to ext...
Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies. Support global regulatory pre-market applications for geographies included but not limited to: Taiwan, Singapore, Australia, Brazil, Korea,...
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. ...
Key Responsibilities : • Manage instruments and accessories regulatory team • Define regulatory strategy for devices and gather necessary intel to inform the strategy and ensure compliance • Manage preparation of regulatory submissions required for device approvals and registrations i...
Position: Senior Regulatory Affairs Specialist Duties: Works collaboratively with Global Regulatory Affairs, Product Development Teams and Product Marketing to register products in the United States. Prepare responses to FDA deficiency letters in support of regulatory clearance/approvals; Maint...
Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies. Support global regulatory pre-market applications for geographies included but not limited to: Taiwan, Singapore, Australia, Brazil, Korea,...
SUMMARY: The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affai...
Duties focus on regulatory affairs. Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or bachelor's degree and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs. Collect and...
The Regulatory Project Coordinator coordinates the processing, reporting, and special projects for the Office of Research Regulatory Affairs. Develop a thorough knowledge of Regulatory Affairs. Assists Regulatory team in document creation and submission. ...
Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH. Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance. Define and document corporate regulatory practices within the Quality Management System t...
The University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation ...
Specialist - Regulatory Affairs - OCTR - Previous CRC lll experience a plus & monitoring/auditing human subjects-152783. Document the conduct of each protocol's regulatory activities in an electronic regulatory system. Upon request from investigators, conduct pre-reviews of draft documents (such as ...
Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements. Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization. Oversee i...
The Senior Specialist evaluates product recipes and raw materials for regulatory compliance; develops ingredient listings and nutrition facts panels, develops RMS (raw material specification) data in support of labeling compliance, helps to identify, develop and substantiate nutrition and ingredient...