- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … regulatory landscape. + Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease ... law. Possess a solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory … more
- Actalent (Lake Forest, CA)
- …global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality, 510(k), Project management, engineering, MDR, ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global...surveillance, FDA , CFR, CFRA Top Skills Details Regulatory ,new product development,quality,510(k) Additional Skills & Qualifications… more
- Schwan's Company (Minneapolis, MN)
- …Qualified Individual (PCQI), providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and special claims to ... excellence across the supply chain? As our Sr Manager , FSQ Regulatory Compliance, you will play...regulatory expert, and manage complex compliance programs including product safety, labeling, import/export, and crisis management. If you… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in ... project team meets US requirements in development activities. The manager will be responsible for FDA meetings...accordance with the project governance model to drive Target Product Profile objectives. + Provides consistent regulatory … 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 ... team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and...systems and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory… more
- Dentsply Sirona (Milford, DE)
- …for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements. This ... regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance… more
- AbbVie (North Chicago, IL)
- …compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). This ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy US and Canada is responsible… more
- CSL Behring (King Of Prussia, PA)
- …to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product /s with a patient-centric ... insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product /s 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...focus on infant,children, and adult categoriesin order to provide regulatory guidance and expertise throughout the whole product… more
- ThermoFisher Scientific (Frederick, MD)
- …is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and ... and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting… more
- Boehringer Ingelheim (Ridgefield, CT)
- …labeling for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product ... of process to support labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling Operations will provide… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups. * Demonstrate proficient and ... Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US package and product ...and prepare regulatory labeling documents needed for regulatory labeling submissions. * Assist with FDA … more
- Stryker (Mahwah, NJ)
- **Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager , Regulatory Affairs** , you ... global regulatory strategies, submission preparation and approvals for new product launches and patient-specific solutions. You will work across the … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …in more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, ... combination of education and experience. + Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations. + Excellent verbal… more
- Oracle (Bismarck, ND)
- **Job Description** This role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA , etc.) and guiding cross-functional ... functions. Excellent communication, documentation, and executive presentation skills. Familiarity with regulatory frameworks (eg, HIPAA, HITRUST, FDA ) and their… more
- J&J Family of Companies (Irvine, CA)
- …Learn more at https://www.jnj.com/medtech We are searching for the best talent for a ** Manager , Regulatory Affairs** . _The preferred location for this role is ... NO remote option and relocation assistance is not provided. **Purpose** : The Manager , Regulatory Affairs, is a mid-level professional responsible for managing… more
- Chiesi (Boston, MA)
- …for the better. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi ... to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
- Oracle (Carson City, NV)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Helena, MT)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more