Sr. Regulatory Affairs Associate Avion PharmaceuticalsSr. Regulatory Affairs AssociateAlpharetta, GeorgiaThe Senior Regulatory Affairs Associate is responsible for preparing submissions in eCTD format, actively participating in client meetings, interacting with the various governmental agencies when needed, and assessing change control for regulatory impact. Proactively work with clients to ensure a successful working relationship by providing information, documentation, and regulatory advice in a timely manner.
Regulatory Affairs Specialist II - Labeling & Promotion Avion PharmaceuticalsRegulatory Affairs Specialist II - Labeling & PromotionAlpharetta, GeorgiaThe Regulatory Affairs Specialist II is responsible for independently preparing submissions in eCTD format, label and promotions participant for Regulatory Affairs in client meetings, interact with the various governmental agencies when needed, and assess promotional and labeling changes for regulatory impact. Independently prepare complete submissions in eCTD format according to supplied checklist(s) – Label supplements, OPDP materials, Annual Reports, and other product correspondence as needed.
Analyst, Regulatory Affairs Oscar Health InsuranceAnalyst, Regulatory AffairsAtlanta, GARemote$28.30–$37.15 / hourYou will support the Regulatory Affairs Evidence of Coverage team by serving as a resource on Oscar processes and identify risks to escalate in partnership with their manager. Responsibilities: Support annual QHP filings by ensuring the quality and timeliness of annual filing inputs through initial submission and regulator facing negotiation periods.
Analyst, Regulatory Affairs Oscar Health IncAnalyst, Regulatory AffairsAtlanta, GARemote$28.30–$37.15 / hourYou will support the Regulatory Affairs Evidence of Coverage team by serving as a resource on Oscar processes and identify risks to escalate in partnership with their manager. Responsibilities: Support annual QHP filings by ensuring the quality and timeliness of annual filing inputs through initial submission and regulator facing negotiation periods.
Senior Regulatory Affairs Specialist - Software OrganOxSenior Regulatory Affairs Specialist - SoftwareAtlanta, GA$115,000–$140,000Under direction from the Director, Regulatory Affairs, Software and Innovation, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices and Regulatory Intelligence. Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Director of Regulatory & Scientific Affairs, Health & Wellness ADMDirector of Regulatory & Scientific Affairs, Health & WellnessKennesaw, GA$151,400–$238,200 / yearThis role works in conjunction with the Global RSA H&W Head, and the cross-functional H&W team to leverage regulatory compliance of the H&W portfolio by leading the assessments of permissibility and suitability in North America (NA) and any registration or process associated, to unlock the market according to the business strategy. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments — environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career.
NewSenior Director I, Scientific & Regulatory Affairs – Compliance & Innovation Coca-ColaSenior Director I, Scientific & Regulatory Affairs – Compliance & InnovationAtlanta, GeorgiaEvaluate and communicate business impact of U.S. federal and state legislative and regulatory developments affecting beverages, including policies related to low- and no-calorie sweeteners (LNCS), sugar reduction, front-of-pack labeling, functional ingredients, caffeine, environmental health issues, and consumer transparency. Role Summary : The Senior Director of Scientific & Regulatory Affairs – Compliance & Innovation enables enterprise-wide growth and innovation by translating evolving food regulations into clear, actionable guidance for commercial, technical, and dedicated innovation teams across the US.
Director of Regulatory & Scientific Affairs, Health & Wellness Archer Daniels Midland CoDirector of Regulatory & Scientific Affairs, Health & WellnessKennesaw, GAThis role works in conjunction with the Global RSA H&W Head, and the cross-functional H&W team to leverage regulatory compliance of the H&W portfolio by leading the assessments of permissibility and suitability in North America (NA) and any registration or process associated, to unlock the market according to the business strategy. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments - environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career.
Regulatory Affairs Specialist Ova TechnologiesRegulatory Affairs SpecialistAlpharetta, GAWe are seeking a detail-oriented Regulatory Affairs Specialist to support regulatory submissions, compliance activities, and product approval processes within the healthcare, pharmaceutical, biotechnology, or medical device industry. The ideal candidate will have strong knowledge of regulatory requirements and experience working with internal teams and regulatory agencies.
Regulatory Affairs Specialist - Supporting China Product Registration Intuitive Surgical IncRegulatory Affairs Specialist - Supporting China Product RegistrationPeachtree Corners, GACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). Solid project management skills, experience of working (as a leader or co-leader or project manager) cross-functionally/regionally to support strategy development, drive planning and execute to time sensitive goals; Cross-cultural (China) RA project related a plus.
Regulatory Affairs Specialist CorDxRegulatory Affairs SpecialistAlpharetta, GAWith over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drug abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Regulatory Affairs Specialist II The Clorox CoRegulatory Affairs Specialist IIAlpharetta, GA$90,900–$170,100 / yearThis role requires strong cross-functional collaboration, working daily with partners across R&D (e.g., Product Development), Product Safety, Legal, Corporate Quality, Government Affairs, and Consumer Affairs. Work with Consumer Affairs to develop consumer-facing responses, providing regulatory guidance to ensure accuracy, consistency, and appropriate interpretation of product claims, ingredients, and safety information.
Regulatory Affairs Specialist (Foods) The Clorox CompanyRegulatory Affairs Specialist (Foods)Alpharetta, GA$90,900–$170,100 / yearThis role requires strong cross-functional collaboration, working daily with partners across R&D (e.g., Product Development), Product Safety, Legal, Corporate Quality, Government Affairs, and Consumer Affairs. Work with Consumer Affairs to develop consumer-facing responses, providing regulatory guidance to ensure accuracy, consistency, and appropriate interpretation of product claims, ingredients, and safety information.
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemoteAtlanta, GeorgiaRemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
Regulatory Affairs Manager (Atlanta) CorDxRegulatory Affairs Manager (Atlanta)Atlanta, GAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Senior Regulatory Affairs Manager (Onsite) CorDxSenior Regulatory Affairs Manager (Onsite)Atlanta, GAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions.
Remote Regulatory Affairs contractor GlobalchannelmanagementRemote Regulatory Affairs contractorAtlanta, GeorgiaRemoteAuthor, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format, Lead submission lifecycle activities, including: Acceptance Review support (RTA readiness). Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance.
Senior Managing Counsel, Regulatory Affairs Mastercard IncSenior Managing Counsel, Regulatory AffairsAtlanta, GA$250,000–$400,000 / yearAll activities involving access to Mastercard assets, information, and networks comes with an inherent risk to the organization and, therefore, it is expected that every person working for, or on behalf of, Mastercard is responsible for information security and must: Abide by Mastercard's security policies and practices; Ensure the confidentiality and integrity of the information being accessed; Report any suspected information security violation or breach, and. The Global Regulatory team is looking for a Senior Managing Counsel, Regulatory to lead the MTS Regulatory team and drive the regulatory compliance program for MTS's global portfolio of money transmission/payment services licenses.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaGA$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
NewSenior Regulatory Affairs Specialist - Clinical MinimedSenior Regulatory Affairs Specialist - ClinicalVirtual, GARemote$97,000–$165,000 / yearIf you are applying to perform work for MiniMed 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 MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Manage projects assigned to support business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products that require clinical evidence.