Principal Regulatory Affairs Specialist-Coronary Vascular

Job TitlePrincipal Regulatory Affairs Specialist-Coronary VascularJob DescriptionThe Principal Regulatory Affairs Specialist will play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant with global regulatory rules and standards. Your role: Advise internal stakeholders...

Principal Regulatory Affairs Specialist, Software (U.S. Hub based)Clinical Integration and Insight (CII) is revolutionizing healthcare delivery at the point of care. Our Capsule Surveillance product is a cutting-edge clinical decision support software medical device (SaMD) that utilizes patented smart rules to provide actionable alerts to clinicians,...

Job TitleRegulatory Affairs SpecialistJob DescriptionLooking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.In this role you have the opportunity toPosition is needed to support...

Job TitleRegulatory Affairs SpecialistJob DescriptionLooking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.In this role you have the opportunity toPosition is needed to support...

Supports Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet cor Regulatory Affairs, Regulatory, Specialist, Operations, Product Development, Healthcare, Business Services,...

Position Overview: As a top-notch Principal Regulatory Affairs (RA) Expert, you will play a crucial role within our Regulatory Affairs team, ensuring compliance with regulatory standards and quality management. Your responsibilities will include working on design control projects, assessing document changes, drafting regulatory submissions, and much more...

Here, we provide our RA/ QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World's Best Workplaces, Regulatory Affairs, Pharmaceutical, Specialist, Regulatory, Remote, Senior, Manufacturing, Technology

Join a team that is changing millions of lives. Transforming smiles, changing lives. At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never...

Who is CorDx?CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19,...

Overview:Responsibilities: Manages team of regulatory and clinical professionals at the Specialist or Manager levels Establishes and executes regulatory and clinical strategies, in cooperation with crossfunctional project teams. Provides guidance to staff on identification of regulatory and clinical requirements and supports staff with the effective...

Overview Werfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity...

The Regulatory Affairs Analyst will support and obtain human subjects and safety committee approvals for oncology clinical trials supported by the HDFCCC CRSO. The analyst works independently, under the direction of the Regulatory Affairs Manager, to Regulatory Affairs, Analyst, Regulatory, Healthcare, Business Services, Manager

MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies...

Prepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines Review regulatory documents to ensure that all submissions are complete, accurate and meet re Regulatory Affairs, Regulatory, Associate, Business Services

You will participate in policy-making meetings and conferences, serving as an advisor on issues related to identifying information that will further the Agency's mission and goals. You will also maintain working relationships with representatives of the media; Federal, state, and local governments; and members of professional, business, civic, and other...

You will participate in policy-making meetings and conferences, serving as an advisor on issues related to identifying information that will further the Agency's mission and goals. You will also maintain working relationships with representatives of the media; Federal, state, and local governments; and members of professional, business, civic, and other...

Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provid Regulatory Affairs, Manager, Regulatory, Senior, Business Partner, Business Services

Responsibilities and Duties:Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictionsOversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissionsConduct regulatory review of submission documentsCoordinate with external publishing...

Be part of a successful established team of 15 energetic cardiologists in beautiful coastal Southern California.Expect to be busy from day one.Join a dynamic team representing various cardiology fields including General, Structural, Peripheral, Electrophysiology, Imaging, Pulmonary Hypertension, and Heart Failure.Work in a one-stop cardiology care facility...

Be part of a successful established team of 15 energetic cardiologists in beautiful coastal Southern California.Expect to be busy from day one.Join a dynamic team representing various cardiology fields including General, Structural, Peripheral, Electrophysiology, Imaging, Pulmonary Hypertension, and Heart Failure.Work in a one-stop cardiology care facility...