- Medtronic (Minneapolis, MN)
- …in a dynamic and fast-paced environment. This position reports to the Senior Program Manager - FDA /Life Sciences, Enterprise Legal Regulatory . This will be an ... **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise...Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team with knowledge and experience navigating requirements… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …advisor to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will ... This position with the Regeneron Regulatory and Commercial Law team will provide proactive...advertising and promotion, and strategic brand planning. + Ensuring compliance with all relevant laws, regulations, policies, procedure and… more
- Schwan's Company (Minneapolis, MN)
- …passionate about driving regulatory excellence across the supply chain? As our Sr Manager , FSQ Regulatory Compliance , you will play a critical role in ... providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and special claims to support safe and compliant… more
- Houston Methodist (Houston, TX)
- …**SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH and ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining ... Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to… more
- Dentsply Sirona (Waltham, MA)
- …an internal champion for initiatives aimed at improving business systems and compliance . Key Responsibilities: + Develops and implements regulatory strategies to ... support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance . +… more
- Boehringer Ingelheim (St. Joseph, MO)
- … regulatory strategies for assigned products/projects within the team and ensure regulatory compliance with regards to safety and efficacy. The position will ... project team meets US requirements in development activities. The manager will be responsible for FDA meetings...Participates in the evaluation of the product dossiers for regulatory compliance and suitability for registration. +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …with the leadership / key stakeholders to identify, prepare, and ensure quality and regulatory compliance and completeness of all submissions into IRIS prior to ... to the CTIP Associate Director for Reg unit, the Regulatory Operations Manager (ROM) will oversee the...oversight of program's clinical trial portfolio and all related regulatory and compliance metrics requirements. Maintains knowledge… more
- Mount Sinai Health System (New York, NY)
- …the Clinical Trials Manager in developing and ensuring clinical trial regulatory compliance . + Coordinates communication with investigators and members of ... **Job Description** A Senior Regulatory Compliance Coordinator position is currently...and obtains approval from the Food and Drug Administration ( FDA ) for investigator-initiated clinical trials. Acts as primary contact… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy US and Canada is responsible ... products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Reckitt (Evansville, IN)
- Regulatory Manager City: Evansville **We are Reckitt** Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why ... in our great organisation. **About the role** This pivotal Regulatory Manager role offers you the opportunity...industry association activities related to US-manufactured products. + Drives regulatory processes to ensure timely FDA filing,… more
- ThermoFisher Scientific (Frederick, MD)
- …regulatory direction to product development teams. + Lead all aspects of regulatory compliance of advertising and promotional materials. + Supervise ... cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a...review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA… more
- AbbVie (Mettawa, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion Immunology combines ... professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence… more
- Stryker (Mahwah, NJ)
- **Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager , Regulatory Affairs** , you ... teams through regulatory communications. + Monitor and implement new regulatory requirements, providing actionable plans to maintain compliance . + Ensure… more
- CSL Behring (King Of Prussia, PA)
- …applicable regulatory systems (eg, Veeva) to ensure tracking and compliance deliverables. + Applies the CSL Leadership Capabilities - Build Bridges, Think ... therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to… more
- Chiesi (Boston, MA)
- …reviewers/approvers to get content approved to support business needs + Ensures regulatory compliance while effectively managing business risks + Understands ... and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing...guidance documents and initiating changes in systems to ensure regulatory compliance . Knowledge of Common Technical Document… more
- Wolters Kluwer (Waltham, MA)
- ** Regulatory Initiatives Product Manager ** Wolters Kluwer is a global leader in professional information and software solutions, trusted by clinicians and ... of healthcare. This is a product management role focused on integrating regulatory and compliance considerations into product strategy and development. **It… more
- Highmark Health (Grove City, PA)
- …and coordinate all activities related to maintaining an ongoing state of regulatory compliance through proactive risk assessments and mitigation efforts. Manage ... risk or deficiency; oversee ongoing monitoring to ensure sustained regulatory compliance . (20%) + Support and participate...Commission, The PA Department of Health, OSHA, and the FDA . In this role, represent the hospital during surveys… more
- J&J Family of Companies (Titusville, NJ)
- …Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance , ... Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager , Regulatory Scientist. This position is a hybrid role… more