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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
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.
Albemarle is hiring for a Regulatory Affairs Specialist. Participate in cross functional product development and commercialization teams as needed, providing guidance on global regulatory requirements and strategies. Execute hazard communication for all products in APAC region, including preparation of Safety Data Sheet (SDS) and labels in SAP-EHS system. Support other Albemarle’s Product Stewardship activities as appropriate and directed. Bachelor’s Degree or above with major in Chemistry, Biology, Environmental Science or other related scientific discipline.
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
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.
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).
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.
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.
The Director, Regulatory Affairs will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/quality management system (QMS) responsibilities.. Empower and enable regulatory affairs and quality team members to foster a culture of collaboration and confident decision-making when working in cross-functional programs and projects.. You've acquired 10+ years of experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device industry, including 3 years' experience and a strong track record in successfully leading/managing Regulatory Affairs and/or Quality teams.. We are a health technology company.. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
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.
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
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
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
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!
We are seeking a Manager with extensive experience in the pesticide industry to join our Regulatory Affairs team. Collaborate with outside Canadian and Mexican consultants (with Sumitomo staff) to manage submissions including new applications, amendments, formulation changes etc. Contribute to the development and approval of Safety Data Sheets (SDS) related to pesticide products, while adhering to compliance standards.. Participate on the docket review committee to evaluate and approve all public information concerning pesticides.. Education~ Bachelor’s Degree in Chemistry, Biology, Entomology, or related field with 7+ years’ experience in Regulatory Compliance/Affairs, in the pesticide consumer products industry working with FIFRA; pet products experience strongly preferred
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).
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.
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.
Determine and document change assessments for EU Class III & IIb devices to ensure compliance with EU Medical Device Regulation.. Plan and prepare submissions for EU Class III & IIb devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to Notified Body questions and requests.. Experience with regulatory submissions to bodies such as FDA, Health Canada, ANVISA/INMETRO, EU Notified Bodies, MHRA, Swissmedic, NMPA, PMDA, MFDS, and TGA is a plus.. Experience with software-driven and electro-mechanical medical devices is a plus.. Ability to work independently and as part of a team in a hybrid/in-person setting (Bedford, MA).
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.