Senior Regulatory Affairs Specialist Varian Medical Systems IncSenior Regulatory Affairs SpecialistNYRemote$117,770–$161,931 / yearIt is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". As a Senior Regulatory Affairs Specialist, you will be responsible to: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
Regulatory Affairs Associate Aurobindo Pharma LtdRegulatory Affairs AssociateEast Windsor, NJDeprecated : preg_replace_callback(): Passing null to parameter #3 ($subject) of type array|string is deprecated in C:\api\public\classes\StringCleaner.class.php on line 100 .
Medical Device Regulatory Affairs Strategist Oracle CorpMedical Device Regulatory Affairs StrategistNYRemote$87,000–$178,100 / yearAs a Principal/Lead/Senior Regulatory Affairs Specialist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). About the Role: At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry.
Regulatory Affairs Compliance Manager PBF EnergyRegulatory Affairs Compliance ManagerParsippany, NJ$106,787.51–$189,503.19 / yearThis role includes day-to-day management of ISCC program requirements and risk management, continuous monitoring of regulatory and system updates, and direct accountability for mass balance, conversion factors, GHG calculations, and audit readiness and execution. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills and internal peer equity will be considered in determining the selected candidate's compensation.
Sr. Staff Regulatory Affairs Specialist VB Spine LLCSr. Staff Regulatory Affairs SpecialistAllendale, NJ$135,000–$145,000 / yearStaff Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll apply broad and advanced knowledge of regulatory frameworks, requirements, legislation, and processes to advise cross-functional teams and leadership on complex projects and strategies - supporting global product development, lifecycle management, and regulatory compliance. At VB Spine, join a high-performing Regulatory Affairs team where you'll provide senior-level strategic guidance that enables the successful global launch and continued compliance of innovative spinal technologies.
Manager, Regulatory Affairs MTF BiologicsManager, Regulatory AffairsEdison, New JerseyFull timeThis role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits, recalls, licensing, labeling and promotional review, quality system documentation, risk management, and design control support. Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies.
Quality Assurance & Regulatory Affairs Manager Marcum SearchQuality Assurance & Regulatory Affairs ManagerNew York, NY$140,000–$150,000 / yearThis hands-on role supports product development, supplier quality, regulatory submissions, import compliance, product testing, and labeling review while enabling innovation and speed to market. CBIZ Talent Solutions is seeking an experienced Quality Assurance/Regulatory Affairs Manager for our CPG client in Midtown Manhattan.
Director, Regulatory Affairs - CMC PTC Therapeutics IncDirector, Regulatory Affairs - CMCWarren, NJ$193,500–$243,600 / yearWorks with GRA functions to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality. This position works cross-functionally with Regulatory Affairs, Technical Operations, Quality, and program teams to facilitate the completion of regulatory submissions through regulatory approvals in accordance with company goals and timelines.
NewRegulatory Affairs Manager Macpower Digital Assets Edge Private LimitedRegulatory Affairs ManagerNew York, NY$43–$55 / hourSummary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Professional Regulatory Affairs - Lifecycle Management - Non-Medicines Perrigo Co PlcProfessional Regulatory Affairs - Lifecycle Management - Non-MedicinesMorristown, NJWe are excited to recruit a Regulatory Affairs Professional within Non-Medicinal Lifecycle Management, you will play an important role in supporting Perrigos non medicinal portfolio including cosmetics, VMS, general products and other non-medicinal classifications such as medical devices across the product lifecycle. You will be responsible for managing lifecycle management activities, including the preparation, maintenance and delivery of regulatory documentation, product information files, technical files, notifications, registrations and supporting records in line with global requirements and business priorities.
Vice President, Food Safety, Quality & Regulatory Affairs DO & CO AGVice President, Food Safety, Quality & Regulatory AffairsJamaica, NY$200,000–$230,000 / yearThe ideal candidate is a transformational leader with extensive experience in multi-site food manufacturing, airline catering, commissary, or high-volume food production environments and a proven ability to build world-class food safety programs that protect consumers, strengthen customer partnerships, and uphold the integrity of the DO & CO brand. DO & CO is seeking an accomplished Vice President of Food Safety, Quality & Regulatory Affairs to provide executive leadership for all food safety, quality assurance, regulatory compliance, sanitation, supplier quality, and product integrity initiatives across our North American operations.
Senior Director, Regulatory Affairs, Advertising, Promotion and Labeling SK Life Science, Inc.Senior Director, Regulatory Affairs, Advertising, Promotion and LabelingParamus, New JerseyFull timeProvide strategic, proactive regulatory guidance on the development of all promotional, advertising, and educational materials across all channels (print, digital, social media, speaker programs, formulary communications) to ensure fair balance and consistency with the US Prescribing Information (USPI). Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for advisory comments and managing responses to enforcement letters.
NewRegulatory Affairs Specialist Benjamin Moore & CoRegulatory Affairs SpecialistMontvale, New Jersey$85,000–$110,000 / yearResponsibilities: Generate Hazard Communication documents, preparing and reviewing Safety Data Sheet and Product Labels, ensuring product safety and regulatory compliance for paints and coatings in North America. Collaborate with cross-functional teams to provide a regulatory perspective for ongoing and upcoming initiatives within the organization and represent Benjamin Moore in industry groups (ACA).
Regulatory Affairs Technician - Food Labeling HiFyveRegulatory Affairs Technician - Food LabelingHicksville, New YorkWe're looking for an experienced Regulatory Affairs Technician to support food labeling, product specifications, and regulatory compliance for a variety of branded, private-label, and bulk food products. This position works closely with Product Development, Quality, Sales, and Art teams to ensure labels, packaging, specifications, and product documentation meet U.S., Canadian, and customer requirements.
Director, Regulatory Affairs Legend Biotech CorpDirector, Regulatory AffairsSomerset, NJ$168,372–$220,988 / yearServes as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.
Regulatory Affairs Compliance Manager PBF Energy IncRegulatory Affairs Compliance ManagerParsippany, NJ$106,787.51–$189,503.19 / yearThis role includes day-to-day management of ISCC program requirements and risk management, continuous monitoring of regulatory and system updates, and direct accountability for mass balance, conversion factors, GHG calculations, and audit readiness and execution. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills and internal peer equity will be considered in determining the selected candidate's compensation.
Director, Regulatory Affairs Eikon Therapeutics, Inc.Director, Regulatory AffairsJersey City, NJ$213,000–$257,250 / yearThis role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner.
NewSenior Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs ManagerNew York, NY$90,000–$140,000 / yearThe Senior Regulatory Affairs Manager ensures regulatory compliance of The client / LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Senior Director, Regulatory Affairs Ardelyx IncSenior Director, Regulatory AffairsNY$259,000–$317,000 / yearPartner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications. Qualifications: Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - Immunology - HybridFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.