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Ultimate Staffing Services is actively seeking a dedicated Regulatory Affairs Specialist to join their client's team in Union City, California. This position will play a crucial role in supporting the Regulatory Affairs department and the broader organization by ensuring compliance with both domestic and international regulations. 8-10 years of experience as a Regulatory Affairs Specialist, with at least 2 years in the medical device industry. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
🚨 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
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.
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).
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 Community Health Center Network. Position Title: Regulatory Affairs Manager. 3+ years of experience in healthcare compliance or regulatory affairs, preferably within a managed care organization, IPA, MSO, TPA, or other delegated entity.. Certification required: Certified in Healthcare Compliance (CHC) or Certified in Healthcare Privacy Compliance (CHPC), issued by the Compliance Certification Board (CCB); or ability to obtain certification within 24 months of hire.. Get notified about new Regulatory Affairs Manager jobs in San Leandro, CA.
Reports to: CISO. Position SummaryWe are seeking a hands-on, detail-driven Manager of Regulatory Affairs to lead and execute regulatory strategy and submissions for our Class II SaMD (Software as a Medical Device) portfolio.. You will play a pivotal role in both strategic planning and tactical execution, working closely with cross-functional teams in software engineering, quality assurance, compliance, and product management.. This is an ideal opportunity for someone who is not only fluent in regulatory requirements but is also ready to roll up their sleeves to get submissions over the finish line.. Exposure to QMS platforms and document control tools.
Title: Regulatory Affairs Associate.. Reporting to: Regulatory Affairs Manager.. We are seeking a highly motivated and results-driven Regulatory Affairs Associate to join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ensuring that medical devices produced by Venus Concept meet all regulatory requirements for countries where the devices are marketed. Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 10 direct markets. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, Venus Epileve, Venus Viva MD and AI.ME. Venus Concept's hair restoration systems include NeoGraft and the ARTAS iX Robotic Hair Restoration system.
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
About Sionna Therapeutics Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis.. Job Description Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein.. This role will provide regulatory guidance and support to cross-functional teams and will report to the Senior Vice President, Global Regulatory Affairs and Quality.. 10+ years of regulatory affairs experience in drug development and product registration activities within the biotech or pharmaceutical industry, with experience in multiple phases of development and within both small and large companies.. Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (e.g., orphan designations, fast track, breakthrough therapy, PRIME).
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
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.
At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. As a company that thrives on teamwork and face-to-face collaboration, Vericel follows a hybrid schedule with in-office days Monday - Thursday in our new Burlington, MA location, and flexibility to work remotely on Fridays. Manages and facilitates preparation of organized and scientifically valid marketing registration applications, supplements, amendments, and variations for drugs, biologics, and devices. Experience with drugs, biologics, and/or medical devices. Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
Our Sandoz flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely.. Masters degree or PhD. in a scientific discipline.. We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility.. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIrelated deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Regulatory Affairs Manager.. LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies. Experience serving as a Regulatory Affairs Manager performing:Laboratory and facility inspections in support of GLP studiesFacility audits as required by GLPsQMS audits of ISO/FDA elementsRegulatory agency inspectionsGCP trainingGCP compliance auditsInternal and external current GMP audits
Vir Biotechnology is looing for a Regulatory Affairs Manager to join the regulatory group.. Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS. Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities. Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema. Traumatic brain injury
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.
Their portfolio spans clean energy technologies and includes both operating and in-development assets across multiple regional transmission organizations (RTOs).. This role is ideal for someone with a strong foundation in energy policy, ISO/RTO engagement, or wholesale power market strategy who’s ready to take on a highly visible, cross-functional position.. Assist in developing and executing the company’s regulatory and stakeholder engagement strategy across PJM, MISO, SPP, and other markets.. 5+ years of experience in energy policy, regulatory affairs, or market operations (ideally in power generation, utilities, consulting, or public sector).. Familiarity with ISO/RTO functions and stakeholder processes (PJM, MISO, SPP preferred).
Provide input and suggestions to the Asst. Director, Regulatory Affairs with respect to improving Learning Center regulatory compliance and/or preventing non-compliance.. As directed, participate in the development, management, negotiation and approvals of regulatory documents for Approved Training Organization (ATO) and Memorandum of Understanding (MOU) agreements, pilot training approval documents, aircraft curriculums, instructor & specialty curriculum approvals, exemptions, waivers for training, simulator, instructors, examiners and training curriculums.. Documented previous minimum experience within a FlightSafety International Learning Center of one to two (1-2) years at the Program Manager level; OR four (4) years minimum experience in similar positions within corporate/charter/airline or military organizations is required.. One to two (1-2) years' experience as a ground school or flight simulator instructor.. Knowledge of classroom, flight simulator and aircraft training techniques and procedures.