- Oracle (Boise, ID)
- …data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering ... files** , hazard analyses, and FMEAs. + Collaborate with Regulatory , MDR Program leadership, and Risk Management ...every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true… more
- Teleflex (Wyomissing, PA)
- …system compliance requirements. The Senior RA Associate will partner with Product Management Regulatory Affairs personnel to support 510(k)s, Canada License ... project time tracking. Maintain submission trackers. * Coordinate worldwide submission change notifications and regulatory impact assessments. Communicate the… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …with project team expectations and regulatory project plan timelines (eg, regulatory strategy, regulatory change assessment, etc.) + Researches and ... power products. Under minimal supervision, the individual develops and executes regulatory strategy for significant change supplements and 510(k) registrations… more
- Carrier (Beverly, MA)
- …design, manufacturing location, firmware/software updates, packaging, vendor changes). + Direct regulatory change notifications or approvals as required. + ... committed to innovation, sustainability, and global impact. **About this role** As the ** Regulatory Affairs & Compliance Lead** at **Sensitech** , you will be the … more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …systems needed for the function including and not limited to CREDO (document management ), PRISM ( regulatory information management system), Global Trackwise, ... investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …for developing and implementing regulatory strategies with the Senior Director, Regulatory Management , WW IPD ("Sr Director Regulatory WWIPD") and ... Infusion Sets. This role reports to the Senior Director, Regulatory Management , WW IPD. The Director provides...and consistency in regulatory strategy, communication with regulatory bodies and change control determination +… more
- Capital One (Mclean, VA)
- …consulting to senior management with respect to onsite supervision and evolving regulatory policy matters. We are seeking a Manager to play an integral role in ... Thrive in a dynamic, fast-paced environment where priorities often change and you manage multiple deliverables simultaneously + Demonstrate...Crave an opportunity to learn and grow in the regulatory affairs and risk management realms **Primary… more
- Citigroup (Getzville, NY)
- …job level, and date of hire. **Most Relevant Skills** Business Acumen, Change Management , Communication, Data Analysis, Financial Acumen, Internal Controls, ... + Working knowledge of related industry practices and standards for data management and regulatory reporting, and experience in large-scale data implementations.… more
- LinkedIn (Mountain View, CA)
- …controls that fulfill legal obligations and align with business needs. + Drive change management initiatives for compliance programs across the organization. + ... regulatory changes impacting LinkedIn. + Support internal and external audits, regulatory inquiries, and enforcement actions + Support management in handling… 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 global ... development projects and provide regulatory strategy for assigned projects that leads to a...dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US… more