Regulatory Affairs Specialist III. The primary purpose of this position is to strategically plan, execute and provide oversight to regulatory activities. US, EU, ISO standards and other regulatory requirements based on geography. Responsible for planning, managing and implementing regulatory strateg...
The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awarene...
The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency...
The Senior Medical Safety Specialist works with minimal supervision on a range of medical safety activities of varying complexity in collaboration with Medical Safety team members and other functions, including Regulatory, Quality/Post-Market vigilance, Risk Management, Complaint Handling, Product D...
The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for blood products and biologics. Review and approve all labeling (pr...
Remote-Spanish-Speaking-Medical Device Regulatory Affairs Specialist II. As a Regulatory Affairs Specialist II you will:. Work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy. Field requests from global regulatory associates fo...
The Specialist II is responsible for Regulatory Affairs support of global regulatory submissions for the BSC product development process, integration of acquired products, and ongoing regulatory compliance. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs emp...
Senior Regulatory Affairs Specialist. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. In this role, you will lead the preparation and submission for regulatory approvals and identify and re...
The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Specialist is responsible for assessment of device changes for regulatory implications. You will have the opportunity to discuss your preferred working l...
The International Regulatory Affairs Specialist provides regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea. Interact with international regulatory partners in local offices to support submission contents, as well as foreign regulatory agency rev...
Regulatory Affairs Specialist II. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Acts as a regulato...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Remote-Spanish-Speaking-Medical Device Regulatory Affairs Specialist II. As a Regulatory Affairs Specialist II you will:. Work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy. Field requests from global regulatory associates fo...
As a Senior Construction Project Manager here at Honeywell, you will be accountable for overseeing and managing geothermal and electrification projects in the Minneapolis, MN area. You will play a critical role in ensuring the successful execution of construction projects, meeting client requirement...
Residential Program Manager Description:. Residential Program Manager Responsibilities. Oversight of site operations and program service delivery including medication administration, coordination of medical appointments, meal planning/preparation, transportation, maintenance, implementation of progr...
This position reports to the Independence Program Director and the duties and responsibilities of this position include:. Oversight of program service delivery. Minimum of three years of supervisory level experience in a program providing direct support services to persons with disabilities or perso...
Manage, review, and control all project costs and maintain accurate project cost projections. Prepare final written analysis on project profitability, profit enhancers, profit busters, and project problems for discussion in the close-out meeting and the permanent project records. Adolfson & Peterson...
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates ...
Varian is seeking an Internal Auditor Program Manager. As the Internal Auditor Program Manager will work cross-functionally with global teams to maintain certifications and a robust quality system, while fostering continuous improvement through training and best practice sharing. Responsible for exe...
Program Manager to work in Ramsey, MN!. Defines when programs are to set up to manage multiple connected projects, and sets up the method and format for this program level management. Receives priorities and program or project specifics and generally can develop, plan and prioritize day to day activ...
Layout and Composition Specialist, 508 Compliance. Layout and Composition Specialist, 508 Compliance. Remediate PDFs for 508 compliance to ensure they. Three years of experience with Section 508 compliance (PDF remediation). ...
The Program Manager has full responsibilities at their assigned program along with supporting other program for on-call coverage. Join our team as a Program Manager at our Edgewood Adult Crisis Program in Crystal. Managers are on-call for their program during the week and rotate being on-call during...
The Pharmacy Program Manager position is a 100% remote role requiring a HIPAA-compliant workspace. A Pharmacy Program Manager is a Clinical Pharmacist providing pharmacist support for an interdisciplinary care management team and members under assigned plan sponsors through conducting comprehensive ...
The Regulatory Affairs Manager is responsible for leading a team of Regulatory professionals with responsibility for developing strategies and executing on regulatory submissions to introduce new products and therapies and maintain existing products to global markets. Minimum 7 years experience in r...
Medtronic Structural Heart is seeking an experienced and highly motivated Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies. Senior Manager, Regulatory Affairs - Structural Hear...