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On-Board Scientific is hiring a Regulatory Affairs Specialist in. Title: Regulatory Affairs Specialist. Bachelor’s degree in Chemistry, Biology, Toxicology, or a related field. Familiarity with OSHA, TSCA, RCRA, and Export regulations is desirable. The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
De Nora is an Italian multinational company, listed on the Euronext Milan stock exchange, a global provider of innovative technologies and solutions, and is recognized as a partner of choice for significant industrial electrochemical processes.. Today, it is the world's largest supplier of high-performing catalytic coatings and insoluble electrodes for electrochemical and industrial applications.. De Nora is committed to developing unconventional solutions to achieve the energy transition to decarbonization, the green hydrogen economy, and clean water for everyone.. De Nora Water Technologies is a leading solutions provider for water treatment with extensive experience in energy, municipal, and industrial applications worldwide.. Cross-Functional Collaboration: work closely with other departments including, Product Management, Product Development, Legal, Marketing, Sales, Procurement, Quality Health & Safety and Environmental (QHSE) and Operations to ensure product compliance.
We are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas.. Lead the development and execution of regulatory strategies across clinical, non-clinical, and CMC areas in partnership with cross-functional teams.. Contribute to global clinical regulatory plans, identify potential risks, and recommend mitigation strategies.. Bachelors degree in a scientific discipline; advanced degree preferred.. Minimum 10 years of regulatory affairs experience, including management of investigational and marketed products.
Apply now for the position of Regulatory Affairs Manager, and you will join our Ultrasound Diagnostic Imaging and become part of a dynamic global community of scientists, engineers, clinicians, developers, and professionals who are pushing the boundaries of what's possible, to improve people's lives around the world.. In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.. It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". Get notified about new Regulatory Affairs Manager jobs in Issaquah, WA. Vice President, Legal Affairs (Litigation, Regulatory & Public Policy)Senior eDiscovery Program Manager, Litigation & Regulatory
The Regulatory Affairs Manager provides leadership, direction, and management in implementing regulatory policies, procedures, and strategies to ensure chemical and product regulatory compliance.. Manage trade compliance with NAFTA, HTS assignments, and provide necessary documentation for import and export activities.. Bachelor's degree in Environmental, Health & Safety or Occupational Health & Safety, Engineering, Chemistry, or related safety/environmental safety degree.. 7+ years of progressive experience in Regulatory Affairs, Product Stewardship, or EHS department at an industrial or manufacturing facility.. Working knowledge of regulations and standards such as GHS, FDA, TSCA, CEPA, DSL, FIFRA, RCRA, etc.
We are seeking a Regulatory Affairs Associate with a Juris Doctor (J.D.) minimum 5 years of healthcare experience , and the ability to work onsite in the Bronx, 5 days per week.. Juris Doctor (J.D.) from an accredited law school.. Sign in to set job alerts for "Regulatory Affairs Associate" roles.. Principal Regulatory Affairs Specialist (SaMD)Associate - Regulatory Compliance (Private Funds)Associate Regulatory Affairs Manager – Beauty & Wellbeing and Personal Care. Associate Regulatory Affairs (Contractor)Associate/Sr. Associate Regulatory Operations, CMC
Medical Laboratory Scientist, Full Time Evenings, Core Lab, CMC Atlantic Health System Pompton Plains, New Jersey.. Medical Laboratory Scientist II Baylor Scott & White Health Fort Worth, Texas.. Health Technician - Pedorthist Amended Veterans Affairs, Veterans Health Administration Vero Beach, Florida.. Medical Laboratory Scientist II Baylor Scott & White Health Irving, Texas.. Medical Supply Technician - Sterile Processing Services Veterans Affairs, Veterans Health Administration Eugene, Oregon
We are seeking a Regulatory Affairs Manager to join our team to lead and broaden the impact of our ongoing regulatory affairs efforts across the United States. Prepare and implement annual (and ad-hoc) strategic planning to detail Scale’s efforts to improve state and ISO/RTO markets for microgrids, including renewable energy, dispatchable generation and battery storage deployment. 5+ years in regulatory affairs, energy policy, or market strategy roles, ideally within renewable energy, utilities, or microgrids. Familiarity with distributed energy technologies (e.g. microgrids, energy storage) and utility program dynamics in one or more key markets is preferred. Scale Microgrids (“Scale”) is a fully integrated distributed energy platform focused on designing, implementing and financing innovative distributed clean energy solutions.
Join to apply for the Director, Regulatory Affairs role at Werfen North America. Werfen, founded in 1966, is a global developer, manufacturer, and distributor of specialized diagnostic instruments, reagents, automation workcells, and data management solutions primarily for hospitals and independent clinical laboratories.. Our North American operations and our headquarters are based in Bedford, MA, with additional technology centers in San Diego, CA, and Orangeburg, NY.. The Regulatory Affairs Director for Autoimmunity will lead and develop a Regulatory Affairs team, overseeing product lifecycle support for instrumentation, hardware, software, and reagents.. Bachelor's degree in a life science, engineering, or related field; advanced degree preferred.
7+ years' experience in food, nutrition, dietary supplements, pharmaceuticals, or a related field. Get notified about new Regulatory Affairs Manager jobs in Torrance, CA. Bilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA CompliancePharmacy Manager - Medication Safety/Regulatory ComplianceFinancial Risk and Regulatory - Resolution Planning - Senior Manager. Financial Risk and Regulatory - Resolution Planning - ManagerHead of Deposit and Operations ComplianceFinancial Risk and Regulatory - Financial Services Liquidity Risk - Manager. Financial Risk and Regulatory - Financial Services Liquidity Risk - Manager
For the LVMH Beauty scope of brands, joining the Regulatory Affairs & External Relations team to lead the operational regulatory affairs team on cosmetics and OTC drugs.. Fluent knowledge on the cosmetic and OTC drug business, and regulatory implications in gaining and maintaining market access in the USA and Canada.. Identifying and actioning opportunities on operational regulatory affairs topics to drive our Beauty business on cosmetic and OTC drug regulations.. Reports to Vice President, Regulatory Affairs & External Relations. Please note that this is a hybrid position based out of our East Brunswick, NJ office, requiring on-site work 3 days per week.
Join to apply for the Regulatory Affairs Manager role at Catalyst Pharmaceuticals, Inc.. Organize and track the internal review process of regulatory documents, including reconciliation of review comments, editing, formatting, version control, and finalization within the Veeva RIM Platform.. Collaborate with Regulatory Operations to enhance regulatory submission and information management capabilities within the Veeva RIM platform.. Solid understanding of Good Clinical Practice (GCP) and end-to-end regulatory submissions and archival processes.. Get notified about new Regulatory Affairs Manager jobs in Coral Gables, FL
Kelly Science & Clinical is seeking a Regulatory Affairs Manager for a direct-hire position at a premier client.. As a Regulatory Affairs Manager , you will operate under the guidance of the Director of Quality Operations to ensure compliance with the company's Quality System and Regulatory Affairs programs.. Serve as Calibration Laboratory Management Representative.. Experience preparing regulatory submissions for FDA, EU MDR, and global markets.. It's the ripple effect that changes and improves everything for your family, your community, and the world.
Join to apply for the Regulatory Affairs Manager role at Capstan Medical. This is a unique opportunity for an experienced Regulatory Affairs professional to join a well-funded, early-stage start-up positioned to revolutionize structural heart care.. The Manager of Regulatory Affairs will help build and execute the regulatory strategy for our novel implant, catheter, and robotic platform products.. We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.. Sign in to set job alerts for "Regulatory Affairs Manager" roles.
We have an unwavering commitment to safely and reliably deliver electricity and natural gas to millions of people.. Manages the development and execution of regulatory policies and strategies in collaboration with internal stakeholders that support CNP’s corporate strategy, goals and objectives with participation of the appropriate CNP groups or departments.. Partners with a cross functional team for the development of recommendations to management for the need and timing of general rate cases and major filings to support CNP’s corporate strategy, goals and objectives.. Maintains good working relationship with regulators, their staffs, internal colleagues including legal, government affairs, rates groups, and customers.. Access to discounts at fitness clubs and an on-site wellness center at our headquarters in Houston
Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.. Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products.. Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving implementation of complex global and local labeling and other regulated solutions in accordance with the end-to-end regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals.. Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions.. Minimum 5 years of pharmaceutical regulatory or regulated content management (e.g., labeling, or Company Core Data Sheets) experience.
WHOOP is seeking a Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory affairs for Medical Device Software in the US. In this role, you will work with the WHOOP Medical Device Team to act as a champion of U.S. Regulatory activities throughout the medical device lifecycle. As a Regulatory Affairs Manager, you will be responsible for various regulatory & quality functions, such as leading regulatory submissions, implementation of quality system processes, collaborating with the WHOOP Medical Device Team throughout the product development process, and ensuring compliance with the Quality Management System (QMS). Implement post-market surveillance, including complaint handling, adverse event reporting (MDR), and field actions.. Bachelors Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience.. Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health or Mobile Medical Applications
Join to apply for the Regulatory Affairs Manager role at cGxPServe. The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.. Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products.. Support global implementation of CCDS/CCSI/RSI into country-specific labelling by developing and approving implementation of complex global and local labelling and other regulated solutions in accordance with the end-to-end regulated content, labelling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals.. Lending Compliance Auditor/Analyst [Part-Time] Manager/Sr. Manager, NERC Regulatory Services Chicago, IL $125,000.00-$160,000.00 1 week ago
Regulatory Affairs Specialist I -.. Hybrid after 30 days M and Tuesdays on site, the third day candidate’s choice. Work Experience: 3-5 years’ experience in IVD regulatory affairs. Laboratory research experience in an IVD medical device regulated environment is strongly preferred. Understanding of scientific reports, risk management, Quality Systems
Johnson Service Group (JSG) is currently looking for a Regulatory Affairs Assistant with a chemistry or chemistry-related degree. At least 1-3 Years of experience in a Product Safety and/or Regulatory Affairs role preferred. EHS or Product Safety experience is a plus with familiarity with EHS regulations such as GHS, DG Classification and TSCA, and Safety Data Sheet (SDS) familiarity and/or authoring experience a big plus.. Responsible for assisting with ensuring compliance with US OSHA and Canadian Workplace Hazardous Materials Information System (WHMIS). This includes gathering, maintaining and correcting data in to the SAP EHS database for the preparation of Safety Data Sheets (SDSs), preparation of data for regulatory reports, and responding to customer requests for information regarding regulatory compliance and products.