- Merck & Co. (Durham, NC)
- …and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be involved in all quality-related activities for computerized ... technology capabilities/solutions with quality policies and objectives. Ensure the initial project tailoring is appropriate for the complexity and risk to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …handles sensitive documents that may impact multiple organizational units or project teams. This position has advanced skills in technology systems, content ... implementation of culture change initiatives, Global QA Transformation activities and project level oversight including end to end risk-based deployment in relation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Provide proactive support and technical assistance during preparation and review of regulatory documents As assigned, participate in project teams Assist with ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director. Works with personnel… more
- Merck & Co. (Durham, NC)
- …comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.- - The Quality Senior Specialist provides expertise in the coordination of ... supporting the vaccine expansion facility. - Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of… more
- Merck & Co. (North Wales, PA)
- …in this role will require strong Veeva CRM and Salesforce knowledge, project management skills and an effective partnership across many functions including Sales, ... and communication as neededFacilitate the integration between marketing / promotion, legal/ regulatory and technical teams to ensure compliance with channel standards… more
- Merck & Co. (North Wales, PA)
- …programs.Maintains working knowledge of promotional review systems and regulatory guidance to effectively deliver compliant assets/programs.Manages the release ... managing multiple projects and stakeholders.Proven problem solving and exceptional project management skills.Strong communications skills and self-motivated mindset. Preferred… more
- West Pharmaceutical Services (Exton, PA)
- Sr . Specialist , Regulatory Project Management (Evergreen Posting) Requisition ID: 67683 Date: Oct 16, 2024 Location: Exton, Pennsylvania, US Department: ... Affairs Description: **Thank you for your interest in our Sr Specialist , Regulatory PM (Evergreen)...and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project… more
- Teleflex (Chelmsford, MA)
- Sr . Regulatory Affairs Specialist **Date:** Oct 23, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... make a difference in patients' lives. **Position Summary** The Sr . Regulatory Affairs Specialist (SRA)...new and modified products. * Assume full responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical… more
- GNC (Pittsburgh, PA)
- …a collaborative environment where you will make a personal impact every day. As the Sr . Regulatory Documentation Specialist , you will be responsible for the ... product registration. What You'll Do: This is a Full-Time Salary Position As a Sr . Regulatory Documentation Specialist , you will manage product registration… more
- Amazon (Sunnyvale, CA)
- …Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr . Regulatory Affairs Specialist will be working to build best ... as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and… more
- Teleflex (Maple Grove, MN)
- Sr . Regulatory Affairs Specialist **Date:** Oct 22, 2024 **Location:** Maple Grove, MN, US **Company:** Teleflex **Expected Travel** : Up to 10% ... communicate regulatory requirements for the strategic manufacturing projects to project and program manager. * Ensure compliance with design controls and good… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …skills. 7. Ability to comprehend technical documents and concepts. **External-Facing Title:** Senior Specialist Regulatory Affairs **Posting Country:** US - ... **12271BR** **Title:** Sr . Specialist , Regulatory Affairs...as sole representative from Regulatory to ensure regulatory compliance. + Depending on product/ project complexity,… more
- Medtronic (Minneapolis, MN)
- …safely and efficiently, with more predictable procedure times and outcomes. The ** Senior Regulatory Affairs Specialist ** develops strategies for worldwide ... taking inputs and incorporating worldwide compliance requirements.Provide on-going support to project teams for regulatory issues and questions.Find, interpret… more
- AltaGas (Springfield, VA)
- **Job Description** **WGL - Sr Replacement Project Management Specialist ** **Position Summary** The Senior Replacement Project Manager Specialist ... project process to accomplish stated Company objectives. Individual will use project management expertise to drive cross functional alignment with scope, budget,… more
- Astellas Pharma (Westborough, MA)
- …Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The Sr Specialist , Manufacturing, Production Planning will be part of the ... ** Sr Manufacturing Specialist , Production Planning** Do...changes are in accordance with AGT's policies and procedures, regulatory requirements, guidelines, and recommendations. As assigned, will serve… more
- Globus Medical, Inc. (Audubon, PA)
- …possible. **Position Summary** **:** Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with ... Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps… more
- Entergy (Jackson, MS)
- …TX, New Orleans, La or Jackson, MS **Job Summary/Purpose** + The Capital Project Procurement Specialist , Senior Staff utilizes extensive supply chain ... delivery of safety, cost, quality, schedule, and customer satisfaction measures. The senior staff specialist operates autonomously and in an advisory capacity… more
- Federal Reserve Bank (San Francisco, CA)
- …examinations, common team horizontal examinations, and supervisory issues follow-up. The ** Sr . Risk Specialist ** position is an excellent opportunity to ... through participation in on-site examinations and regular monitoring of business activities. The Sr ./Lead Risk Specialist will work closely with DST and system… more
- Southwest Power Pool (Little Rock, AR)
- …multiple business and technical functions relating to Generation Interconnection Studies. The Senior Specialist is also expected to successfully contribute to ... include modelling development, power flow analysis. The Generation Interconnection Senior Tariff Services Specialist will be able...experience in the electrical industry or related experience + Sr Tariff Service Specialist - Seven (7)… more
