Collecting information
Organizing data
Join our team as a day shift , full-time , Medical Surgical 3 West Patient Care Technician (PCT) in Westwood, NJ. Hackensack Meridian Pascack Valley Medical Center is a 128-bed, full-service, acute-care community hospital with a new emergency department, a state-of-the-art maternity center, a women's imaging center, and an ICU. The Patient Care Tech works alongside doctors, nurses, and other healthcare professionals to provide direct patient care in a variety of healthcare environments.. The Patient Care Technician I plays a vital role in the healthcare delivery setting, often having more patient contact than any other team member, including doctors and nurses.. Certified Nursing Assistant (CNA)
🚨 Now Hiring: Regulatory Affairs Specialist (Medical Device). We’re looking for a highly organized and detail-oriented Regulatory Affairs Specialist to support a global medical device regulatory project.. Dig into Windchill to extract reports, protocols, and supporting data. Experience working with document control systems like Windchill. Build experience in regulatory operations and cross-border compliance
You’ll thrive in a culture of belonging where you and your unique viewpoint matter.. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.. The Regulatory Affairs Principal is responsible for serving as RA lead on New Product Development (NPD) core teams, working on medium to complicated assay, instrument, software projects and/or system projects.. Bachelor’s degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) with 8+ years of related work experience OR Master's degree in applicable field with 6+ years of related work experience OR Doctoral degree in applicable field with 3+ years of related work experience. Serves as RA lead on new product (NPD) core teams including medium to complicated assay, instrument or software projects and complies, prepares, reviews, and submits regulatory submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ).
Our client operates as a developer, owner, operator, and investor in power generation and other electric infrastructure in the United States. Their portfolio consists of multiple wind farms, solar photovoltaic power projects, battery storage facilities, and more. Stay abreast of legislative matters, including working with the lobbyist, forming company position on bills, as relevant to our client business in the West. BS or BA in Political Science, Marketing, Public Policy, Engineering, or an Energy Sector related field. Ability to travel to company offices and the various state government and legislative meetings when required.
Join to apply for the Regulatory Affairs Advisor role at Johnson Matthey. As a Regulatory Affairs Advisor, working as part of the Product Stewardship and Sustainability team, you’ll contribute to JM’s mission as a world leader in sustainable technology, transforming energy and reducing carbon emissions for a cleaner, brighter future.. Supporting the delivery of robust regulatory affairs services to the Catalyst Technologies business, as part of a newly formed Catalyst Technologies Product Stewardship function, to meet business requirements in line with service delivery expectations.. Review and interpret regulatory information from registration dossiers/Chemical Safety Reports, and ensure relevant data are entered into the Safety Data Sheet system and communicated via SDS. In depth knowledge of global chemical hazard classification, labelling and packaging legislation (GHS, CLP), REACH and global equivalents, Waste, COMAH, Poison Centres, etc.
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.
Manager, Regulatory Operations Documentation Specialist - Contractor. Senior Scientist/Associate Director, Regulatory Affairs CMC. Senior Scientist/Associate Director, Regulatory Affairs CMCAssociate Director, Global Regulatory Affairs, Strategy. Senior Manager, CMC Regulatory Affairs – Small MoleculesCounsel - Corporate Contracts and Regulatory Affairs. Vice President, Global Regulatory AffairsManager, Regulatory Operations Documentation Specialist (Contractor)Regulatory Affairs Regional Associate Director, LACan
The Regulatory Affairs Manager is responsible for leading regulatory functions and serves as management representative.. Oversee, supervise, and provide direction in the following areas: Regulatory Strategy, Product Registration and Market Clearance, Device History Record Review, Employee Training, Design History File Maintenance, and Labeling.. Assess the impact of changes on current clinical investigations and FDA filings.. Bachelor's Degree or equivalent is required; Minimum of 10 years progressively responsible experience in the medical device industry is required; Minimum of 7 years within quality systems and/or regulatory compliance functions is required.. This position is subject up to travel up to 15% of the time to include both domestic and international travel.
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
Job Title: Regulatory Affairs Specialist.. The Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in international markets or research use only (RUO) products globally. Minimum year’s experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Experience with flow cytometry, hematology, and/or immunoassay are a plus. Current knowledge of Quality System Regulations (QSR); EU IVDD, Laser product registrations; Machinery Directive and European quality system standards preferred
Job Title: Regulatory Affairs Specialist – Cosmetics & Personal Care. We've partnered with a leading company in the personal care and cosmetics industry to hire their next Regulatory Affairs Specialist!. We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to support the development, registration, and global compliance of cosmetic and personal care products.. Sign in to set job alerts for "Regulatory Affairs Specialist" roles.. Regulatory Affairs Specialist – Beauty & Personal CareRegulatory Advertising and Promotional Review - ContractorRegulatory and Medical Affairs - Senior Medical Information Customer Engagement LeadRegulatory Affairs Compliance Sr. Specialist
At Peoples Gas, we work to make lives better throughout Florida with safe, resilient, clean and affordable natural gas solutions. Whether it’s your first job or your next big move, Peoples Gas is a growing company with career opportunities that fit your future. Peoples Gas System is the fastest growing natural gas utility in the Southeast with career opportunities that fit your future. This highly visible position is responsible for the coordination and development of interactions between Peoples Gas and the Florida Public Service Commission (FPSC) and other related regulatory groups (within and outside Florida), for monitoring and communicating regulatory developments and for maintaining favorable regulatory relations. Serve as Peoples Gas’ Tallahassee contact for the State Emergency Operations Center when necessary: During emergencies provide information regarding outages, system restoration and other information to the State EOC or appropriate contact; participate in EOC drills and exercises; participate in development of Peoples Gas’ emergency operation policies and procedures.
A renowned medical organization is looking to immediately hire a Full-time board-certified Family Practice/Internal Medicine Doctor to work as a Primary Care Medical Director in two offices in Clifton and paerson, New Jersey.. DEA Certification: Current DEA (Drug Enforcement Administration) certification for prescribing medications.. Clinical Acumen: In-depth primary care, preventive medicine, and chronic disease management knowledge.. Tech-savvy: Proficiency with electronic health records (EHR) systems and essential healthcare IT tools for clinical documentation and reporting.. Risk Management: Experience with patient safety initiatives, infection control, and risk mitigation strategies.
Designed for retail clinics and private practices, our platform is currently undergoing FDA review and aims to revolutionize routine blood testing by making it more accessible, affordable, and actionable.. Truvian is seeking an experienced and hands-on Senior Regulatory Affairs Manager to lead and execute all aspects of the company’s global regulatory strategy.. Support the regulatory strategy for Truvian’s portfolio of IVD products, ensuring proactive planning and timely execution of submissions to FDA (510(k), CLIA Waiver), Health Canada, European Notified Bodies (CE Mark/IVDR), and other international agencies.. Bachelor’s degree in Life Sciences, Engineering, or a related discipline required; advanced degree (MS, PhD, PharmD) strongly preferred.. Wellness Perks:On-site gym and fitness classesAccess to a farm-to-table café with a 30% employee discountKombucha, cold brew, and healthy snacks are always on tap
The position will support regulatory intelligence including monitoring regulatory news and updates and summarizing and circulating the same.. Department - Regulatory Affairs. Support on petition filings.. Support regulatory intelligence work involving monitoring updates and news and. Knowledge about Pharmaceutical Product Development.
The Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs compliance and operations activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation and submission of electronic drug, biologic, and device applications.. Serve as Liaison for third party service providers supporting Nuclear Medicine.. Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc. Requirements/Education Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
This position will manage all regulatory affairs activities for categories in the US. Labeling, product development compliance, package development, SDS and ingredients statement generation, customer and regulatory compliance needs, consumer regulatory inquiries, and the safety and efficacy of ingredients. Stay abreast of advancements in toxicology research and contribute to the development of safer and more sustainable products. Bachelors or Graduate degree in a science related field, law or regulatory science, business administration or public health preferred.. Family Support: 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
Job Title: Regulatory Affairs Specialist. Senior Regulatory Affairs Manager. Job Summary: Regulatory Affairs Specialist will help ensure that all cosmetic and topical OTC products comply with local, national, and international regulations.. Help evaluate claims based on internal and external requests, such as “vegan”, “Clean at Sephora”, etc.. 1 to 2 years of experience in Regulatory Affairs within the cosmetic and topical OTC industry.
The Regulatory Affairs position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices).. 510(k) and/or De Novo submissions for FDA.. Technical documentation for EU MDR compliance.. Complete QMS training activities and provide regulatory expertise to continuous improvement activities.. 5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices.
The Regulatory Affairs Associate (RAA) supports the RA team in creating, evaluating and completing regulatory tasks related to worldwide product registration submissions, facility registrations, special projects and strategy to drive market growth worldwide.. Develop and maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory operations and ensure clear, compliant, and auditable processes.. Support the review and evaluation of product, manufacturing, and labeling changes to determine regulatory reporting requirements and ensure ongoing compliance.. Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires.. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries.