Lead Regulatory Affairs Consultant

Position Overview We are seeking a Senior Regulatory Affairs Specialist to join our dedicated team. This role is essential in navigating the regulatory landscape for our innovative products. Key Responsibilities Act as a vital member of the regulatory product team, focusing on Transfusion Medicine initiatives. Facilitate essential regulatory...

Position Overview We are seeking a Senior Regulatory Affairs Specialist to join our dedicated team. This role is pivotal in ensuring compliance with regulatory standards and facilitating the market entry of our innovative products. Key Responsibilities Act as a vital member of the regulatory product team within the Transfusion Medicine sector. ...

Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesParticipate as a regulatory functional product team member for the...

Position Overview:As a Senior Compliance Auditor, you will play a crucial role in ensuring adherence to regulatory standards and quality systems across Abbott's manufacturing facilities. Key Responsibilities:In this role, you will: - Conduct comprehensive audits of Quality Systems in alignment with industry regulations and Abbott's internal procedures. -...

Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at Blue Star Partners LLC. As a key member of our quality assurance team, you will be responsible for leading and supporting validation efforts for various projects.Key ResponsibilitiesLead and support validation efforts for various projects, ensuring compliance with regulatory...

Job SummaryRose International is seeking a highly skilled Document Specialist to support the US Transparency Manager in documentation and daily operations of the transparency and reporting process. This role is a hybrid combination of administrative/documentation, data analysis, and serving as a contact point for internal customer questions and day-to-day...

At Titan Innovations, we pioneer innovative solutions. As a technology leader in mechanical tunneling, we create powerful underground infrastructures worldwide. With our technology and unique expertise, we tackle major challenges in the supply and disposal of scarce and precious resources, as well as in the mobility of tomorrow, and solve them sustainably....

Position OverviewThe role of Quality Assurance Program Manager is essential for ensuring compliance and excellence within Abbott's operational framework. This position focuses on managing external audits and inspections related to Abbott's Quality Management System, providing strategic leadership and project oversight across various business units.In this...

**About Abbott**Abbott is a leading global healthcare company that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.**Our Mission**At Abbott, we are committed to...

Position Overview The Principal Field Clinical Procedure Specialist operates Remotely within the Cardiac Rhythm Management Division at Abbott. As a frontrunner in Cardiac Rhythm Technologies, we are dedicated to pioneering solutions that enhance the treatment of heart arrhythmias, or irregular heartbeats. Key Responsibilities Establishes and...

Position OverviewThis role is integral to the Quality and Regulatory division at Abbott, focusing on the management of external evaluations concerning Abbott's Quality System. The Quality Assurance Manager is responsible for leading initiatives related to inspection readiness, offering strategic direction and project oversight in support of various business...

Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at Blue Star Partners LLC. As a key member of our quality assurance team, you will be responsible for leading and supporting validation efforts for various projects.Key ResponsibilitiesLead and support validation efforts for various projects, ensuring compliance with regulatory...

About the RoleWe are seeking a highly experienced and skilled Area Vice President to lead our Structural Heart business in the United States. As a key member of our leadership team, you will be responsible for driving business growth, developing and executing strategic plans, and building a high-performing team.Key ResponsibilitiesDevelop and execute...

Position Overview:The Enterprise Architect is pivotal in steering projects that encompass various systems within the domains of Quality, Regulatory, and Engineering. This role demands a profound technical acumen to guide the development and support of application systems and programming requirements, ensuring they align with business objectives.Key...

Position Overview:The Enterprise Architect plays a crucial role in overseeing the execution of projects that integrate various systems within the Quality, Regulatory, and Engineering sectors.Key Responsibilities:Ensure the successful delivery of complex projects by providing expert technical guidance in the development and maintenance of application...

Position Overview:The Enterprise Architect is a pivotal role responsible for the successful execution of projects that span multiple systems within the Quality, Regulatory, and Engineering sectors.Key Responsibilities:Deliver comprehensive technical guidance and expertise in the development and maintenance of application systems, ensuring alignment with...

Company OverviewAbbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our diverse portfolio includes innovative technologies across diagnostics, medical devices, nutrition, and branded generic medicines. With a workforce of 114,000 professionals, we serve...

Company OverviewAbbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our diverse portfolio encompasses groundbreaking technologies across various sectors, including diagnostics, medical devices, nutrition, and branded generic medicines. With a workforce of...

The Opportunity Our location in Irving, TX or Abbott Park, IL currently has an opportunity for a Senior Regulatory Affairs Specialist. What You’ll Work On Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Supports necessary regulatory activities required for...

The Opportunity Our location in Irving, TX or Abbott Park, IL currently has an opportunity for a Senior Regulatory Affairs Specialist. What You’ll Work On Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Supports necessary regulatory activities required for...

Overview: The Senior Regulatory Affairs Specialist (CMC) plays a crucial role in providing comprehensive support to the regulatory Chemistry, Manufacturing, and Controls (CMC) division, across various regions and stages of product development. Responsibilities may encompass the organization, management, and execution of regulatory CMC initiatives to...

Job Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Innova Solutions. As a Regulatory Affairs Manager, you will be responsible for developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout the...

Job Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Innova Solutions. As a Regulatory Affairs Manager, you will be responsible for developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout the...

Job Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Innova Solutions. As a key member of our product development and global registration team, you will be responsible for developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout...

Assist the Betco Regulatory Affairs department in a variety of research projects, regulatory submissions, and customer requests. The potential work areas are listed below. The preferred candidate will be expected to learn, assist, and manage certain work areas. Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned as needed): ...

Industry Sector: BiopharmaceuticalsWhy Explore This Career Opportunity:This position offers the flexibility of working remotely while supporting Pacific Time operations.There are ample opportunities for professional development and advancement within the company.The work environment is dynamic and values strong interpersonal skills.Engage in significant...

Position Overview:Collaborate with a cross-functional team to provide comprehensive regulatory support for both new product launches and existing product lines. Engage with quality teams, engineers, and technical experts to address and resolve regulatory issues and inquiries from regulatory agencies.Key Responsibilities:Offer regulatory guidance and input to...

Job DescriptionJob DescriptionPosition Overview:Collaborate with a cross-functional team to provide comprehensive regulatory support for both new product launches and existing product lines. Engage with quality teams, engineers, and technical experts to address and resolve regulatory issues and inquiries from regulatory agencies.Key Responsibilities:Offer...

Position Overview:Collaborate with a cross-functional team to provide comprehensive regulatory support for both new product launches and existing product lines. Engage with quality teams, engineers, and technical experts to address and resolve regulatory issues and inquiries from regulatory agencies.Key Responsibilities:Offer regulatory guidance and input to...

Description: Note: Fully remote Scope The Project's objective is to design and configure regulatory authoring templates that are needed for deployment of automation software for use in preparing chemistry, manufacturing, and controls (CMC) regulatory applications (ex. Module 3 of the ICH Common Technical Document). The project leverages 2 primary...

Hawkins Ash CPAs is seeking to recruit a Lead Audit Consultant for our team.At Hawkins Ash CPAs, we prioritize your professional journey and personal development. We promote and support both individual and career advancement while empowering our leaders. Our workplace fosters a culture of inclusivity, encouraging everyone to share their ideas and viewpoints...

HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...

OverviewClient is looking for an individual contributor who will support the US Transparency Manager in documentation and daily operations of the transparency & reporting process. This role is a hybrid combination of administrative/documentation, data analysis, and serving as a contact point for internal customer questions and day-to-day...

Our client, in the healthcare industry, is seeking a Instructional Designer to join their team.   Job Title: Organizational Change Management Lead Location: North Chicago, IL​​​​​​​ OVERVIEW Organizational Change Management (OCM) Lead will play a key role in ensuring all change initiatives associated with IT projects meet objectives by...

Innova Solutions is immediately hiring for an Project Manager Position type: Full-time; ContractDuration: 04+ MonthsLocation: Remote Pay range: $65 - $71/hr on W2 As a Project Manager Professional you will: Job Description:Ideal candidate: Prefered PMP certified. confident in leading conversations, Must be able to manage Projects. Process improvements...

At Associated Bank we strive to create an inclusive culture where different perspectives are valued and recognized as strengths critical to our success. If you thrive in an environment where your growth and development are encouraged and supported, then Associated Bank may be the right place for you. Leadership role within the Controller Group. Responsible...