- We are seeking someone who can coordinate communications between State CLIA COLA programs Center Management facilitate information sharing resolve problems provide guidance Plasma Centers compliance FDA regulations applicable international requirements timely accurate processing lookbacks consistent regulatory requirements customer specifications analyze final reports accuracy provide accurate timely information customers serve primary contact regarding CLIA COLA programs evaluate Post Donation Error/Accident Reports determine threshold Biological Product Deviation Reporting prepare submit BPDRs FDA maintain statistical data relating EAR/PDIs/BPDRs generate resolution letters Plasma Center records assist investigations DMS change requests donor number errors test hold removals track incoming outgoing paperwork ensure FIFO processing prioritize processing update departmental SOPs required filing faxing copying mailing paperwork reports
- Familiarity cGMP procedures high degree attention detail ability understand interpret government regulations customer specifications recognize need appropriate changes relative procedures work high-pressure deadline-driven environment minimum 2 years experience plasma related field laboratory cGMP environment Bachelor Degree preferred offset equivalent experience general office experience helpful typing customer service plasma center operations preferred
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We currently have an exciting opportunity available for a Manager, Regulatory Affairs · Supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies like U.S. Food and Drug Administration. · Serves as a ...
Boca Raton2 months ago
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We currently have an exciting opportunity available for a Manager, Regulatory Affairs · ...
Boca Raton1 month ago
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We currently have an exciting opportunity available for a Regulatory Affairs Manager. · ...
Boca Raton1 month ago
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We currently have an exciting opportunity available for a · Manager, Regulatory Affairs · Job Title: Manager, Regulatory Affairs · Serves as a liaison with regulatory agencies and contractors. · Evaluates regulatory documents for submission to governmental regulatory agencies li ...
Boca Raton, FL2 months ago
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ADMA Biologics is a biopharmaceutical company that creates products for immunodeficient patients. The company has an opening for a Regulatory Affairs Associate to coordinate and execute their lookback program. · Provide guidance on FDA regulations and compliance. · Coordinate com ...
Boca Raton2 months ago
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We currently have an exciting opportunity available for an · Associate, Regulatory Affairs · Candidate should be responsible for coordinating and executing ADMA Biologics lookback program. Coordinate communications between State, CLIA, and COLA programs with Center Management. C ...
Boca Raton1 month ago
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+Job summary · A dynamic and innovative company in the biopharmaceutical industry is looking for a Regulatory Affairs Associate to coordinate and execute their lookback program. · +ResponsibilitiesCoordinate communications between State, CLIA, and COLA programs with Center Manage ...
Boca Raton1 month ago
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We currently have an exciting opportunity available for an · Associate, Regulatory Affairs. · Coordinate and execute ADMA Biologics lookback program. · ...
Boca Raton, FL2 months ago
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· We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dy ...
Plantation, FL, US $80,000 - $140,000 (USD) per year1 week ago
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Advancing Psychiatric & CNS Clinical Research · Next Phase Research is a growing medical research organization specializing in psychiatry and central nervous system (CNS) clinical trials. We are committed to advancing innovative treatments while delivering exceptional patient car ...
Hollywood, FL $80,000 - $140,000 (USD) per year1 day ago
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+p+The+Regulatory+A+ffairs+Specialist+is+responsible+fro+m+s+t+t+rporating+rregulatory+cimpliance+a+citivties+fro+m+a+well-established+m+dmedical+dvice+organization+a+nnd+s+suring+porductsmeet+a+ppllable+lUS,,a,+nd+iinternational+rregulatoory+rrequirements+t+hroughout+ttheir+life ...
Pompano Beach3 weeks ago
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The Regulatory Affairs Specialist oversees all regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. · ...
Pompano Beach3 weeks ago
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The Regulatory Affairs Specialist is responsible for supporting regulatory compliance activities for a well-established medical device organization and ensuring products meet applicable U.S. and international regulatory requirements throughout their lifecycle. · ...
Pompano Beach $75,000 - $85,000 (USD)2 weeks ago
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The Regulatory Affairs Specialist is responsible for supporting regulatory compliance activities and ensuring products meet applicable U.S. and international regulatory requirements throughout their lifecycle. · ...
Pompano Beach, FL2 weeks ago
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+Job Summary · About Us At Trividia Health we are committed to improving lives through innovative diagnostic solutions As a leader in the medical device and in vitro diagnostics IVD industry we strive for excellence in regulatory compliance quality and customer satisfaction We ar ...
Fort Lauderdale Full time1 month ago
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We are seeking an experienced Director of Regulatory Affairs to lead our regulatory efforts across global markets. · Lead U.S. regulatory submissions including 510(k)s CLIA waivers and FDA correspondence. · Develop and execute global regulatory strategies for new existing IVD pro ...
Fort Lauderdale, FL1 month ago
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· Company Description · Headquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide. · This is a great step for someone ...
Plantation, FL1 week ago
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This job involves supporting the regulatory side of the business to ensure compliance with corporate procedures and timely product approvals with domestic and international regulatory requirements. · Assist in the preparation of US, EU, and rest of world regulatory submissions as ...
Fort Lauderdale1 month ago
- Work in company
Manager Patient Safety Regulatory Affairs, Corp Quality & Accred Ops, FT, 8:30A-5P
Only for registered members
The Manager is responsible for assessing processes and practices for regulatory reporting and conformance to quality standards especially in the area of patient safety. · ...
Boynton Beach $112,081 - $149,068 (USD)1 month ago
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The Senior Associate will guide day-to-day execution of Elusys' Government Affairs strategy and will closely coordinate with other team members on the Government Affairs and Operations teams... · ...
Boca Raton $65,000 - $100,000 (USD) Full time2 weeks ago
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Quality control specialist with experience in pharmaceutical injectable manufacturing environment. · Minimum 8 years of relevant experience and sound knowledge of cGMP regulations. · Perform analysis of raw materials and finished products. · Evaluate analytical results for batc ...
Boca Raton3 weeks ago
Associate, Regulatory Affairs - Boca Raton - ADMA BIOMANUFACTURING LLC
Description
At ADMA Biologics, we are dedicated to creating superior products for immunodeficient patients at risk for infection. Our commitment to this underserved population drives us and our hands-on approach to production and development sets us apart.
Associate Regulatory Affairs Role
This is an exciting opportunity for a dynamic individual with regulatory affairs experience in the biopharmaceutical industry.
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Manager, Regulatory Affairs
Only for registered members Boca Raton
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Manager, Regulatory Affairs
Only for registered members Boca Raton
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Manager, Regulatory Affairs
Only for registered members Boca Raton
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Manager, Regulatory Affairs
Only for registered members Boca Raton, FL
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Associate, Regulatory Affairs
Only for registered members Boca Raton
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Associate, Regulatory Affairs
Only for registered members Boca Raton
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Associate, Regulatory Affairs
Only for registered members Boca Raton
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Associate, Regulatory Affairs
Only for registered members Boca Raton, FL
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Regulatory Affairs
Only for registered members Plantation, FL, US
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Regulatory Affairs
Only for registered members Hollywood, FL
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Specialist, Regulatory Affairs
Only for registered members Pompano Beach
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Regulatory Affairs Specialist
Only for registered members Pompano Beach
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Regulatory Affairs Specialist
Only for registered members Pompano Beach
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Regulatory Affairs Specialist
Only for registered members Pompano Beach, FL
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Director, Regulatory Affairs
Full time Only for registered members Fort Lauderdale
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Director, Regulatory Affairs
Only for registered members Fort Lauderdale, FL
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Regulatory Affairs Manager
Only for registered members Plantation, FL
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Regulatory Affairs Associate II
Only for registered members Fort Lauderdale
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Manager Patient Safety Regulatory Affairs, Corp Quality & Accred Ops, FT, 8:30A-5P
Only for registered members Boynton Beach
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Senior Associate
Full time Only for registered members Boca Raton
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Quality Control – Injectables
Only for registered members Boca Raton