Regulatory Affairs Specialist
hace 2 semanas
Job Summary
Staar Surgical is seeking a highly skilled Regulatory Affairs Intern to assist with FDA and international regulatory submissions. The ideal candidate will have a strong understanding of medical devices regulations and terminologies, as well as excellent written and oral communication skills.
Main Responsibilities
Assist with coordination of essential documents and tools for regulatory submissions
Conduct quality checks for compliance with applicable regulations
Prepare and maintain annual renewals of Establishment Registrations and other pertinent domestic and international licensing
Compile information necessary for periodic reports for Regulatory filings
Review and interpret regulatory rules and ensure they are included in company practices
Review complex reports and validations for scientific merit and regulatory appropriateness
Review and edit communications, including memos, correspondence, and presentations
Develop and review procedures for compliance with regulatory requirements
Participate in Health Authority Inspections and support remediation teams
Requirements
B.A./B.S. degree in Regulatory Science or related field
One or two years of work experience preferred
Strong knowledge of FDA and international regulations
Excellent written and oral communication skills
Ability to work in a team setting
-
Regulatory Affairs Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico Abbott A tiempo completoAbout the RoleAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.Job SummaryWe are seeking a highly skilled Regulatory Affairs...
-
Regulatory Affairs Specialist
hace 4 semanas
San Juan, San Juan, Puerto Rico Staar Surgical A tiempo completoRegulatory Affairs InternJob Summary: We are seeking a highly motivated and detail-oriented Regulatory Affairs Intern to assist our team with FDA and international regulatory submissions.Main Responsibilities:Coordinate regulatory submissions, including preparation of essential documents and quality checks for compliance with applicable regulations.Prepare...
-
Regulatory Affairs Manager
hace 4 semanas
San Juan, San Juan, Puerto Rico Jobleads-Us A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences Istanbul Office.The successful candidate will be responsible for managing RA submissions and Clinical Trials applications, interacting with local Regulatory Authorities and other stakeholders to ensure compliance with country-specific...
-
Regulatory Affairs Specialist I
hace 3 semanas
San Juan, San Juan, Puerto Rico Abbott Laboratories Company A tiempo completoAbout AbbottAbbott is a leading global healthcare company that helps people live more fully at all stages of life. Our diverse portfolio of life-changing technologies and products spans the spectrum of healthcare, from diagnostics and medical devices to nutritionals and branded generic medicines.The OpportunityThis role is part of our Infectious Disease...
-
Regulatory Compliance Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico Oriental Bank In San Juan A tiempo completoAbout This RoleThe Regulatory Compliance Specialist will play a key role in ensuring the organization's compliance with federal and state consumer protection laws and regulations. This individual will work closely with the Corporate Regulatory Compliance Unit Manager to develop, maintain, and monitor the Compliance Annual Plan.Key Responsibilities* Achieve...
-
Compliance Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico Target Human Resources Solutions A tiempo completoAbout the JobTarget Human Resources Solutions is seeking an experienced Compliance Specialist to join our team. The successful candidate will be responsible for performing ongoing risk assessment activities focused on regulatory and compliance areas associated with organizational operations and performance.Key ResponsibilitiesThe Compliance Specialist will...
-
Regulatory Compliance Expert
hace 2 semanas
San Juan, San Juan, Puerto Rico Protalents A tiempo completoJob SummaryThe Compliance Specialist will perform ongoing risk assessment activities focused on regulatory and compliance areas associated with organizational operations and performance. This key individual will be accountable for elaborating and overseeing regulatory & compliance matters designed to assess and evaluate adequacy, effectiveness and compliance...
-
Regulatory Compliance Expert
hace 1 semana
San Juan, San Juan, Puerto Rico Protalents A tiempo completoRole SummaryThe Compliance Specialist will perform ongoing risk assessment activities focused on regulatory and compliance areas associated with organizational operations and performance. This key individual will be accountable for elaborating and overseeing regulatory & compliance matters designed to assess and evaluate adequacy, effectiveness and...
-
San Juan, San Juan, Puerto Rico Jobleads-Us A tiempo completoJob Summary: We are seeking a highly experienced Senior Director to lead our Medical and Scientific Affairs team in the Infectious Disease business. As a key member of our senior leadership team, you will be responsible for developing and implementing medical and scientific strategies for our global product portfolio.Key Responsibilities:Develop and execute...
-
Regulatory Validation Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico Sharetech Group A tiempo completoWe are seeking a skilled Validation Consultant to plan, execute, and document validation activities for equipment, processes, and systems ensuring compliance with regulatory standards and internal quality requirements. This role is crucial in maintaining our commitment to delivering safe and effective products to our customers.Some key responsibilities of...
-
Regulatory Compliance Specialist
hace 7 días
San Juan, San Juan, Puerto Rico FM Global A tiempo completoAbout FM Global FM Global is a leading property insurer of the world's largest businesses, providing more than one-third of FORTUNE 1000-size companies with engineering-based risk management and property insurance solutions. Our goal is to help clients maintain continuity in their business operations by leveraging state-of-the-art loss-prevention...
-
Regulatory Compliance Expert
hace 7 días
San Juan, San Juan, Puerto Rico Intelligence Llc A tiempo completoCompany Overview: Intelligence Llc is a forward-thinking organization seeking a skilled Regulatory Compliance Officer to join our team. This role requires a detail-oriented professional with experience in regulatory compliance and program management.
-
Mortgage Operations Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico Oriental A tiempo completoMortgage Operations SpecialistWe are seeking a skilled Mortgage Operations Specialist to join our team at Oriental. The ideal candidate will have a strong analytical background and excellent communication skills to effectively review mortgage loan files and ensure compliance with regulatory requirements.Main Responsibilities: * Perform regular reviews of...
-
Mortgage Loan Review Specialist
hace 4 semanas
San Juan, San Juan, Puerto Rico Oriental A tiempo completoMortgage Loan Review SpecialistThe Mortgage Loan Review Specialist at Oriental will be responsible for reviewing mortgage loan files to ensure compliance with regulatory requirements and investors' guidelines. This role will involve analyzing loan documentation, identifying exceptions, and implementing corrective actions to maintain quality and...
-
Compliance Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico Popular Bank A tiempo completoJob Summary:We are seeking a skilled Compliance Specialist to join our team at Popular Bank. As a Compliance Specialist, you will be responsible for monitoring and analyzing transactions to ensure compliance with Bank Secrecy Act (BSA), USA Patriot Act, Anti-Money Laundering (AML), and other regulatory requirements.Key Responsibilities:Monitor and analyze...
-
Quality Assurance Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico MG STAFFING GROUP A tiempo completoJob Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at MG STAFFING GROUP. The successful candidate will be responsible for providing oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and...
-
Clinical Development Physician
hace 2 semanas
San Juan, San Juan, Puerto Rico Bristol-Myers Squibb A tiempo completoAbout This RoleAs a Clinical Development Physician in our Immunology team, you will play a critical role in the development of innovative treatments for patients with immunological disorders. You will be responsible for leading clinical trials, developing clinical strategies, and collaborating with cross-functional teams to bring new therapies to market.Key...
-
Quality Assurance Specialist
hace 4 semanas
San Juan, San Juan, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoJob SummaryFlexible & Integrated Technical Services, LLC is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with policies and performance standards in the Manufacturing area. This role requires a strong understanding of global regulatory requirements...
-
Automation Systems Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico PSC Biotech Corporation A tiempo completoJob OverviewPSC Biotech Corporation is seeking an experienced Automation Systems Specialist to join our team. As an Automation Systems Specialist, you will play a key role in designing, developing, and implementing automation solutions that enhance the efficiency and productivity of our clients' operations.Key ResponsibilitiesCollaborate with clients and...
-
Business Development Specialist
hace 2 semanas
San Juan, San Juan, Puerto Rico Oriental A tiempo completoJob Title: Business Development SpecialistJob Summary:The Business Development Specialist is responsible for the acquisition of new customers through the sale of commercial loans, commercial deposits, cash management services, and Point of Sales and investment referrals. The ideal candidate will have a proven track record of success in business development,...