NewRegulatory Affairs Specialist JouléRegulatory Affairs SpecialistTrumbull, CT$30–$35 / hourli>Skills — strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Regulatory Affairs Specialist Regulatory Affairs Specialist LanceSoft IncRegulatory Affairs Specialist Regulatory Affairs SpecialistRocky Hill, CT$26–$26 / hourul>Ensure that our customers and employees are fully informed about the health and safety characteristics of our products and raw materials and that all products marketed by Henkel Corporation are in compliance with all appropriate regulations (Federal, State, County, regional and/or local.). We have an urgent opportunity for Regulatory Affairs Specialist role with one of our direct clients at Rocky Hill, CT and I feel that your expertise in required background makes you a perfect fit for this role.
Regulatory Affairs Specialist Yale UniversityRegulatory Affairs SpecialistConnecticutThe Regulatory Affairs Specialist 1 will independently monitor their workload intensity and track deadlines to ensure prompt submission and/or completion and proper regulatory reporting and compliance deliverables are met, including recording and reporting requisite metrics for CTO leadership and departmental stakeholders. Collaborating directly with investigators, sponsors, and other key stakeholders within Yale CTO, as well as colleagues across the research enterprise, this role participates in the advancement of critical strategic objectives that promote effective, efficient, and compliant management of Cancer Center clinical research studies.
NewRegulatory Affairs Specialist ZobilityRegulatory Affairs SpecialistTrumbull, CTPlease visit www.zobility.com to learn more. Strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful.
NewRegulatory Affairs Specialist LanceSoft IncRegulatory Affairs SpecialistTrumbull, CT$35–$45 / hourstrong>Skills, experience and qualifications:At least 5 years of experience in pesticide product registration; or equivalent combination of education and experience, including preparation and submission of pesticide registration applications, product labels, offers-to-pay, data matrices, etc. Responsibilities:This is work in pesticide product registration and compliance requiring an entrepreneurial attitude, and enthusiasm for supporting business development and technical efforts supporting new end-use product registrations.
Senior Regulatory Affairs Specialist HyperfineSenior Regulatory Affairs SpecialistGuilford, CT$130,000–$150,000 / yearul>Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations:Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Ensure regulatory submissions are authored according to applicable requirements and guidelines (as assigned) including, but not limited to:US FDA 510(k) submissions.
NewSenior Regulatory Affairs Specialist Hyperfine | AI-Powered Portable MRISenior Regulatory Affairs SpecialistGuilford, CT$130,000–$150,000 / yearh5>Key Responsibilities: Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations: Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. They also assess and advise on regulatory strategy to the organization and design teams; including development of global regulatory strategies product change evaluations impacting regulatory filings worldwide.
Regulatory Specialist Element Solutions IncRegulatory SpecialistWaterbury, CT$62,000–$93,000 / yearFor example, in-care technology, from infotainment to driver assistance, is accelerating the paste of new product development and automotive markets, and with a deep market expertise in electronics, we sit at the intersection of the fast-growing market, changing the competitive playing field for automotive manufacturers, with a long-standing presence. Developed in multi-step technological processes, our innovative solutions enable our customer manufacturing processes in several key segments, including electronic circuitry, communication infrastructure, automotive systems, industrial surface finishing, and offshore energy.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecNorth Haven, CTThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer IngelheimSenior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBERidgefield, CT$170,000–$269,000 / yearIf you want to apply for the position in Germany , please use this link: Senior Regulatory Affairs Manager CMC for NBE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NBE-Germ/1271415301/) and/or Senior Regulatory Affairs Manager CMC for NCE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NCE-Germ/1271422201/). + Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.
Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer IngelheimExecutive Director, Regulatory Affairs, Advertising and PromotionRidgefield, CT$250,000–$394,000 / yearThe Executive Director oversees and develops a team of regulatory professionals specializing in Rx drug advertising and promotion, representing the function within the Regulatory Affairs leadership team and supporting global discussions, training, and alignment on U.S. FDA promotional requirements. The role provides strategic leadership across promotional review governance, shapes internal policy through participation in the Human Pharmaceuticals Review Committee, and strengthens regulatory intelligence through cross‑functional and external partnerships.
Senior Manager, Regulatory Affairs Hyperfine IncSenior Manager, Regulatory AffairsGuilford, CT$162,000–$186,000 / yearp>Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop system-the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. The Senior Manager, Regulatory Affairs owns and executes U.S. and international regulatory strategy for the company's Class II MRI devices and Class I accessory devices across the product lifecycle-from development through commercialization and post-market change management.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsHARTFORD, CT$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer IngelheimRegulatory Affairs Labeling Operations AI Innovation Co-opRidgefield, CT$20–$33 / hourIn the Regulatory Affairs Labeling Ops AI Innovation Co-Op role, your work will help modernize labeling operations through artificial intelligence, automation, and digital solutions—directly impacting how we deliver compliant, patient-centered labeling and regulatory content. This role is focused on utilizing artificial intelligence, automation tools, and digital solutions to modernize labeling operations workflows, drive greater accuracy, seamless system integration, and enhanced operational efficiency.
Senior Manager, Regulatory Affairs HyperfineSenior Manager, Regulatory AffairsGuilford, CT$162,000–$186,000 / yearp>Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Demonstrated success leading U.S. and OUS submissions and sustaining activities for Class I and Class II medical devices (preferably imaging/MRI), including managing questions/deficiencies to clearance/approval.
Prin Regulatory Strategy Spec Medtronic PlcPrin Regulatory Strategy SpecCTp>If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
NewSenior Manager, Global Regulatory Affairs Otsuka America PharmaceuticalSenior Manager, Global Regulatory AffairsHartford, CTp>Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
Senior Director Global Regulatory Lead - Oncology Eli Lilly and CoSenior Director Global Regulatory Lead - OncologyStamford, CT$169,500–$248,600 / yearOur current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are aligned to the Global Brand Development (GBD)/global program team and business priorities in terms of the programs value proposition, workflow, product labeling, risk management, and issues management.
NewSenior Regulatory Compliance Lead - Consumer Products StrivectorSenior Regulatory Compliance Lead - Consumer ProductsTrumbull, CTThe ideal Senior Regulatory Compliance Lead – Consumer Products would be someone with deep experience in many (if not all) of the following: Minimum 10 years of experience in regulatory affairs, regulatory compliance, or product stewardship within consumer products, household chemicals, or similar industries. One of the best in the industry Minimum Education: Bachelor's degree Minimum Experience: Minimum 10 years of experience in regulatory affairs, regulatory compliance, or product stewardship within consumer products, household chemicals, or similar industries.
NewSr. Clinical Trials Transparency & Disclosure Specialist Celldex Therapeutics IncSr. Clinical Trials Transparency & Disclosure SpecialistNew Haven, CT$87,831–$114,066 / yearp>Working collaboratively with Clinical Operations, Regulatory Affairs, Biostatistics, Medical Writing, Legal, and other cross-functional stakeholders, the Clinical Trials Transparency & Disclosure Specialist serves as a subject matter expert for transparency and disclosure requirements across the development portfolio. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compliance Specialist Actalent IncCompliance SpecialistCT$31–$36 / hourWe are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Community Relations Specialist Eversource EnergyCommunity Relations SpecialistEast Hampton, CT$95,140–$105,710 / yearp>Supports various internal partners by sharing municipal and community knowledge to move projects towards successful outcomes while balancing company and community needs during small-scale project meetings, municipal project briefings, and town/city council, board, commission, committee and other municipal organization meetings. Essential Functions: Works with the Community Relations Team to implement strategies for community and municipal outreach and relationship development; emergency preparedness and response; local and regional economic development; strategic corporate giving; and employee engagement, volunteerism, and business membership activities.
Senior Clinical Program Leader/ Clinical Program Leader- Cardio Renal Metabolic Boehringer IngelheimSenior Clinical Program Leader/ Clinical Program Leader- Cardio Renal MetabolicRidgefield, CT$220,000–$350,000 / yeardefinition of Target Product Profiles, Clinical Development Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development. • Serves as Innovation Team Lead of the cross-functional Innovation Team dependent on project stage and proposes members in collaboration which represents the Innovation Team at the Innovation Unit Portfolio Committee (IUPC), IU Executive Committee (IUEC), and the One Human Pharma Committee (OneHP).
Clinical Quality & Performance Improvement RN - On Site Trinity HealthClinical Quality & Performance Improvement RN - On SiteHartford, CTli>Oversee performance improvement activities to ensure mechanisms are in place to prevent avoidable harm and to meet regulatory compliance with the CMS Conditions of Participation, Quality Assurance and Performance Improvement (QAPI) program, The Joint Commission and the Connecticut Department of Public Health. Implements and maintains a compliant and comprehensive, organization-wide, Quality and Performance Improvement Process to address performance opportunities impacting the quality of care delivery to meet regulatory requirements for Saint Francis Hospital (SFH) and Mt.
Senior Clinical Program Leader/ Clinical Program Leader- Cardio Renal Metabolic Boehringer Ingelheim International GmbHSenior Clinical Program Leader/ Clinical Program Leader- Cardio Renal MetabolicRidgefield, CT$220,000–$350,000 / yeardefinition of Target Product Profiles, Clinical Development Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development. • Serves as Innovation Team Lead of the cross-functional Innovation Team dependent on project stage and proposes members in collaboration which represents the Innovation Team at the Innovation Unit Portfolio Committee (IUPC), IU Executive Committee (IUEC), and the One Human Pharma Committee (OneHP).
Submission Manager Boehringer Ingelheim International GmbHSubmission ManagerRidgefield, CT$90,000–$147,000 / yearWith guidance and supervision from supervisor and/or Senior Submission Manager, the Submission Manager is responsible for leading and coordinating the global compilation and worldwide submission of dossiers for new chemical and biological marketing authorization applications, complex life cycle dossiers and the related health authority responses based on regulatory strategies. Manages the planning, preparation and submission of original marketing authorization applications, complex lifecycle dossiers and related responses to health authorities in collaboration with RA sub team and contributing disciplines, with support and supervision from supervisor and/or Specialist IV.
Senior Technical Architect & Developer The Cooper Companies IncSenior Technical Architect & DeveloperCTThis role focuses on translating approved business and functional requirements into technical solutions, supporting system enhancements, integrations, and validation activities under the guidance of senior architects and product owners. The Windchill PLM Technical Architect & Developer works closely with Business Analysts, Quality, Regulatory Affairs, Engineering and other business stakeholders to support the implementation, enhancement, and maintenance of the Windchill PLM solution.
Managed Services Sr. Consultant Deloitte Touche Tohmatsu LtdManaged Services Sr. ConsultantCT$120,200–$140,000 / yearLead and contribute to end-to-end delivery for Generis CARA and associated regulatory technology platforms - including requirements gathering, solution design, system configuration, content template development, and user acceptance testing. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Manager, Product Engineering (Research & Development) The Cooper Companies IncManager, Product Engineering (Research & Development)Trumbull, CTp>Interfaces cross-functionally with R&D, Quality, Regulatory Affairs, Operations, Marketing, and external suppliers to deliver product enhancements, address field issues, and ensure ongoing product reliability and compliance. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place.
Product Surveillance Senior Supervisor The Cooper Companies IncProduct Surveillance Senior SupervisorTrumbull, CT$90,000–$120,000 / yearThis role leads cross‑functional collaboration with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, Supply Chain, and external partners to drive effective complaint resolution, post‑market risk evaluation, and data alignment, and oversee verification of investigation conclusions and corrective actions, ensuring the integrity and traceability of complaint and post‑market surveillance records, and maintain audit‑ready documentation, and will also coach and mentor Product Surveillance personnel, promote consistent investigative practices, and serve as a subject‑matter expert during internal and external audits and inspections, develop and present routine post‑market surveillance metrics and trending analysis to leadership and drive continuous improvement of post‑market surveillance and Quality Management System processes based on investigation outcomes, risk signals, and evolving regulatory expectations. This role ensures the consistent, compliant, and scientifically sound execution of risk‑based complaint investigations through effective application of investigation methodologies, root cause analysis, and risk assessment principles, and has accountability for investigation quality, prioritization, escalation decisions, and inspection readiness, while driving cross‑functional alignment and continuous improvement of the Product Surveillance function in support of product safety, regulatory compliance, and patient protection.