- Cepheid (Miami, FL)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of the Quality ... compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will ... way people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations** will… more
- J&J Family of Companies (Santa Clara, CA)
- …United States of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Manager , Regulatory Compliance - Shockwave Medical** to join our team ... for the treatment of calcified plaque. **JOB SUMMARY** The Regulatory Compliance Senior Manager provides... requirements in the light of current guidance and FDA /International regulatory body field activity. **REQUIRED KNOWLEDGE,… more
- ITW (Rogers, MN)
- …with exceptional opportunities for personal and career development. We are seeking a Regulatory Compliance Manager whose primary role is to ensure ... for NDT services. Qualifications: + 2 years of experience minimum in regulatory compliance , preferably in medical devices, industrial equipment, or… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... projects and roles. Essential Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain… 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...sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across… 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
- Abbott (Santa Clara, CA)
- …in Santa Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within **Abbott ... support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals... compliance with company policies and procedures (eg compliance with FDA , BSI, EEO regulations, etc.).… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs, Precision Medicine, you will help develop ... regulatory strategy in alignment with the drug global regulatory strategy and in compliance with the...diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and… more
- Charles River Laboratories (Charleston, SC)
- …Certification in regulatory compliance or related fields (eg, CRCM, Certified Regulatory Compliance Manager ) is a plus. + Familiarity with Global ... **Job Summary** We are seeking a detail-oriented and knowledgeable Regulatory Compliance Engineer to ensure our products,... bodies. **Key Responsibilities** + Interpret and apply relevant regulatory and industry standards (eg, ISO, FDA ,… more
- Abbott (Sylmar, CA)
- …Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management Business. This ... The Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge of US… more
- AbbVie (San Francisco, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & Canada position is ... products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in… more
- Takeda Pharmaceuticals (Boston, MA)
- …ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance ; Assist the Global Regulatory Lead with Health ... the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs, Marketed Products **POSITION DESCRIPTION** :… more
- Hologic (Marlborough, MA)
- …looking for a Regulatory Affairs Manager , responsible for on-market regulatory activities associated with US FDA , EU Notified Body, and other ... Manager , Regulatory Affairs (IVD On-Market/Sustaining) San...labeling, manufacturing, and analytical and clinical study plans for regulatory compliance + Maintains advanced working knowledge… more
- Kelly Services (Valencia, CA)
- …in a similar role. + Proven experience with 5 years or more of FDA submissions and international regulatory compliance . + Lead Auditor certification ... + ** Regulatory Affairs Manager ** + **Location:** Onsite...for a leading client. In this role, you'll ensure compliance with FDA , ISO, and international regulations… more
- Tecomet (Manchester, NH)
- …The role is critical in maintaining Tecomet's quality reputation, ensuring regulatory compliance , driving process improvements, reducing compliance ... **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality...compliant; + Oversee supplier qualification, audits, performance monitoring, and regulatory compliance of supply chain partners; +… more
- Bausch Health (Bothell, WA)
- …itwhere your skills and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations for their ... changes. Risk Management and Reporting + Conduct risk assessments related to regulatory compliance , helping the company identify potential non- compliance … more
- Amazon (Phoenix, AZ)
- …will manage several Pharmacists in Charge within a geographic region. The Senior Manager Regulatory Ops is responsible for maintaining adherence to regulatory ... Description Amazon Pharmacy is seeking a Senior Manager , Regulatory Operations who is dedicated...Operations who is dedicated to patient safety to ensure compliance with regulatory requirements to deliver on… more
- Philips (Murrysville, PA)
- …responsible for enhancing tracking and controlling systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust ... The Regulatory Affairs Program Manager will play...Leads strategic initiatives towards enhanced performance to further improve regulatory compliance efforts and reviews the creation… more
- Kentucky Blood Center (Lexington, KY)
- …regulatory agencies and accrediting organizations. The position is responsible for KBC's compliance with applicable AABB, FDA , CLIA, State, OSHA, EU, and ... to ensure compliance and the fulfillment of quality initiatives and regulatory requirements. + Participates in training activities, as assigned. + Functions as … more
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