A company is looking for an Associate Director, Regulatory Affairs. ...
Be a versatile regulatory affairs department team member and produce work-product commensurate with professionalism and of the highest quality standards to submit to regulatory authorities for review and approvals. Provides regulatory affairs guidance and support to Plasma Operations, Center Managem...
This role, which reports to the company’s Executive Vice President of Regulatory Strategy & Government Affairs, focuses on public and regulatory affairs at the state and local level across our national footprint. This position will work cross-functionally with the compliance, legal, corporate commun...
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...
Regulatory Affairs Specialist to join our team. This role involves collaboration across various departments, providing regulatory guidance, and managing submissions to regulatory bodies. Regulatory Affairs Certification (US or EU) preferred. Regulatory Affairs, including preparation of submissions t...
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...
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Regulatory Affairs experience in a pharmaceutical, biotechnology, medical device, or related environment. Master in Regulatory Affairs preferred. Regulatory C...
Regulatory Affairs & Contract Management Manager will oversee the Compliance & Contracts while running and enhancing a companywide compliance program ensuring compliance of Business Practices. Monitors and keeps leadership abreast of regulatory issues, deficiencies, or potential problems tha...
You will take a leading role within the Regulatory & Quality Management team and work closely with C-Level as well as our engineering teams to ensure our mixed reality platform is in compliance with regulatory and statutory requirements. Lead the development of regulatory responses for questions...
The Regulatory Affairs Manager is responsible for working to support regulatory and compliance and ensure compliance with applicable regulations and standards governing the manufacturing, labeling, marketing, and distribution of all products. Maintain comprehensive documentation and records related ...
The Quality and Regulatory Affairs Specialist is responsible for providing quality and regulatory affairs services, including Drug Master File (DMF) updates, GMP requests from Health Authorities, customer product complaint investigations, annual product reviews, and management of Change Control and ...
Minimum of 5 years of relevant work experience related to regulatory affairs. Professional certification related to regulatory affairs. The Regulatory Affairs Coordinator is responsible for:. Significant understanding of FDA, GCP & ICH guidelines and regulatory trends and changes. ...
The Regulatory Affairs Manager is responsible for working to support regulatory and compliance and ensure compliance with applicable regulations and standards governing the manufacturing, labeling, marketing, and distribution of all products. Maintain comprehensive documentation and records related...
Qualifications: Bachelor’s Degree with 4 yrs of related regulatory experience is required Regulatory Affairs Certification (RAC) a plus Familiarity with International Medical Device registration requirements (Canada, Europe, China, Japan, Brazil, Russia, etc. The RA Specialist will be self-dir...
Create and maintain comprehensive documentation related to regulatory compliance activities, including regulatory submissions, certifications, and correspondence with regulatory agencies. As the Regulatory Affairs Manager, you will collaborate closely with the leadership team to ensure compliance wi...
The Program Manager, Regulatory& Accreditation Affairs is responsible for leading the Nemours Children’s Health, Florida Regulatory and Accreditation program, and managing the respective team(s). The Program Manager is expected to collaborate with the Director, Patient Care Services leaders, and oth...
In coordination with Regulatory Affairs management, this role will assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations for Arthrex’s medical devices. Specialist, Regulatory Affairs - E...
Be a versatile regulatory affairs department team member and produce work-product commensurate with professionalism and of the highest quality standards to submit to regulatory authorities for review and approvals. Provides regulatory affairs guidance and support to Plasma Operations, Center Managem...
You will take a leading role within the Regulatory & Quality Management team and work closely with C-Level as well as our engineering teams to ensure our mixed reality platform is in compliance with regulatory and statutory requirements. Lead the development of regulatory responses for questions...
The Program Manager, Regulatory& Accreditation Affairs is responsible for leading the Nemours Children's Health, Florida Regulatory and Accreditation program, and managing the respective team(s). The Program Manager is expected to collaborate with the Director, Patient Care Services leaders, and oth...
OPEN POSITION: Vice President of Regulatory Affairs - Medicare Advantage Health Plan COMPENSATION: - $150,000 to $175,000 Base Salary, negotiable based on experience - Annual Bonus - Health / Dental / Vision / Life Insurance - LTD / STD / D&D Insurance - Paid Time Off Package - 401k ...
Leading and enabling strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips international markets organiz...
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. A minimum of years' experience in Regulato...