regulatory affairs Jobs

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Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLC

Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents.

CMC Regulatory Affairs Manager

TechSpace Solutions Inc.

Remote

Contract, Third Party

Job Title : CMC Regulatory Affairs Manager Location : Remote Duration : 12 Months Responsibilities: Leading project teams, ensuring maintenance of team records and process-related documentation i.e., process maps, job aids, project trackers, checklists, etc.Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for

Regulatory Affairs Specialist III

Mitchell Martin, Inc.

Fort Worth, Texas, USA

Full-time, Contract

Our client, is a Swiss-American pharmaceutical and medical device company, is seeking a Regulatory Affairs Specialist Location: Fort Worth, TX Position Type: ContractJob Description: * Support the NBL Manager in Lifecycle Change Management projects. * Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of regulatory support, review and approval of applications with the demonstrated ability to act independently to execute to foster and drive

Regulatory Affairs US Biologicals labeling specialist

Pyramid Consulting, Inc.

De Soto, Kansas, USA

Contract

Immediate need for a talented Regulatory Affairs US Biologicals labeling specialist. This is a 18+ Months contract opportunity with long-term potential and is located in DeSoto, KS (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 24-24845 Pay Range: $20 - $26/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: A

Regulatory Affairs

Judge Group, Inc.

Palo Alto, California, USA

Full-time

Location: Palo Alto, CA Salary: $50.00 USD Hourly - $68.00 USD Hourly Description: Our client is currently seeking a Regulatory Affairs for a 12 month + contract. Hybrid position, 2 days in office (Palo Alto, CA). Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements * Identifies, analyzes and implements country specific requirements necessary for product related submis

Senior Regulatory Affairs

Thermo Fisher Scientific

High Point, North Carolina, USA

Full-time

Job Description When you join us at Thermo Fisher Scientific, you'll be part of a hard-working and driven team that shares your passion for exploration and discovery. With revenues of approximately $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. Ranked #69 on the 2023 Fortune 500 list, you'll discover endless opportunities to grow a rewarding career as part of the world leader in servin

Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

Remote

Contract

Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities- -Authoring US FDA 510(k) submission using eSTAR submission tool.

Regulatory Affairs Specialist

Ledgent Technology

Irvine, California, USA

Contract

Summary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Key Responsibilities: * Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in c

Research Intern - Scientific & Regulatory Affairs - Health Futures

Microsoft Corporation

Redmond, Washington, USA

Full-time

Research Internships at Microsoft provide a dynamic environment for research careers with a network of world-class research labs led by globally-recognized scientists and engineers, who pursue innovation in a range of scientific and technical disciplines to help solve complex challenges in diverse fields, including computing, healthcare, economics, and the environment. This position is for a research internship with the Microsoft Health Futures group at Microsoft Research in Redmond (US). Micros

Regulatory Affairs Specialist II (Wound Closure & Healing) - Ethicon, Inc.

Johnson & Johnson

Raritan, New Jersey, USA

Full-time

Description Ethicon, Inc., part of Johnson & Johnson MedTech, is currently recruiting for a Regulatory Affairs Specialist II to support our Wound Closure & Healing business. The preferred location for this role is within a commutable distance of Raritan, NJ however remote options within the United States will be considered on a case-by-case basis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world w

Regulatory Affairs Specialist II (DePuy Synthes) - Medical Device Business Services, Inc.)

Johnson & Johnson

Warsaw, Indiana, USA

Full-time

Description DePuy Synthes, Inc ., part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Regulatory Affairs Specialist II for the Joint Reconstruction team. This role will work a Flex/Hybrid schedule and must be located within a commutable distance of Warsaw, IN, Raynham, MA, or Leeds, UK. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevent

Senior Regulatory Affairs Specialist - Cardiac Surgery (hybrid)

Medtronic

Mounds View, Minnesota, USA

Full-time

Senior Regulatory Affairs Specialist - Cardiac Surgery (hybrid) Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio. Key Technologies Surgical heart valves Cardiac OR solutions (e.g., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting (CABG) solutions Join a diverse

Manager, Regulatory Affairs Strategic Labeling (Oncology)

Abbvie

North Chicago, Illinois, USA

Full-time

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram,

Principal Regulatory Affairs Specialist - Cardiac Surgery (Hybrid)

Medtronic

Mounds View, Minnesota, USA

Full-time

PRINCIPAL REGULATORY AFFAIRS SPECIALIST - CARDIAC SURGERY (Hybrid) Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio. Key Technologies Surgical heart valves Cardiac OR solutions (e.g., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting (CABG) solutions Join a dive

Business Systems Analyst - Regulatory Affairs

Abbvie

North Chicago, Illinois, USA

Full-time

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram,

Senior Regulatory Affairs Specialist - Cardiac Rhythm Management (hybrid)

Medtronic

Mounds View, Minnesota, USA

Full-time

Senior Regulatory Affairs Specialist - Cardiac Rhythm Management (hybrid) Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Join a diverse team of innovators who brin

Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

Amgen Inc

District of Columbia, USA

Full-time

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 products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Regulatory Affairs Senior Director - Global

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

Amgen Inc

District of Columbia, USA

Full-time

HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in thi

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, California, USA

Full-time

Description The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Tech sector within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Program Lead for International Registration, as part of the Regulatory Affairs Global Execution team, located in Irvine, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are sma

Regulatory Affairs Consultant

Stellar Consulting Solutions

Arkansas, USA

Full-time

Stellar Consulting Solutions is a boutique business & technology consulting company headquartered in Atlanta, GA. We deliver high quality, agile, and experienced workforce for niche technology projects of any scale. We help forward thinking clients to solve specific problems by understanding their needs and align talent that can move fluidly to match skill supply and demand on a real-time basis. Stellar Consulting has a unique combination of technical and digital skills to recruit, engage, and