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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.

Global Regulatory lead - Associate Director

Dizer Corp

Millburn, New Jersey, USA

Contract, Third Party

Title - Global Regulatory Lead - Associate Director Location - Short Hills, NJ Develop global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. Responsibilities: Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic dir

Regulatory & Medical Affairs - Project Manager

Sunrise Systems, Inc.

Lawrence Township, New Jersey, USA

Contract

Job Title: Regulatory & Medical Affairs - Project Manager Job ID: 24-01565 Location: Lawrence Township, NJ, 08648 Duration: 06 Months contract on W2 Onsite full time at Princeton Pike. Innovation and Digital Health, Project Manager - Digital Optimization Initiatives Position Summary The Innovation Lab team partners with R&D stakeholders to design and deliver innovative analytics solutions that help them make better decisions, reduce costs and/or drive efficiencies. Our diverse analytics team of

Regulatory & Medical Affairs - Project Manager

Net2Source Inc.

Lawrence Township, New Jersey, USA

Contract

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.Job Description: Onsite full time at Princet

Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for a remote based opportunity 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. Support document workf

Associate Director-Full Stack (Sr Mgr-App Dev)

Verizon

Bernards, New Jersey, USA

Full-time

When you join Verizon Verizon is one of the world's leading providers of technology and communications services, transforming the way we connect around the world. We're a human network that reaches across the globe and works behind the scenes. We anticipate, lead, and believe that listening is where learning begins. In crisis and in celebration, we come together-lifting up our communities and striving to make an impact to move the world forward. If you're fueled by purpose, and powered by persis

(Senior Manager) Associate Digital Product Manager, Finance, Commercialization & Enabling Functions

Genmab

Princeton, New Jersey, USA

Full-time

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Opportunity:

(Senior Manager) Associate Digital Product Manager, Finance, Commercialization & Enabling Functions

Genmab

Princeton, New Jersey, USA

Full-time

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Opportunity:

Senior Associate - Platform Reliability Engineer - Cloud Technology

New York Life Insurance Company

Lebanon, New Jersey, USA

Full-time

Location Designation: Hybrid When you join New York Life, you're joining a company that values career development, collaboration, innovation, and inclusiveness. We want employees to feel proud about being part of a company that is committed to doing the right thing. You'll have the opportunity to grow your career while developing personally and professionally through various resources and programs. New York Life is a relationship-based company and appreciates how both virtual and in-person inter

Sr Nutritionist (Remote)

Nestle USA

Remote or Bridgewater, New Jersey, USA

Full-time

At Nestl Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life , Nature's Bounty , Vital Proteins , Orgain , Nuun , BOOST , Carnation Breakfast Essentials , Peptamen , Compleat Organic Blends , and more. We also have extensive pharmaceutical expertise, offeri

Senior Risk Adjustment Coding Specialist

Kforce Technology Staffing

Remote or Seattle, Washington, USA

Full-time

RESPONSIBILITIES: Kforce's Seattle, WA Healthcare Client is growing their Risk Adjustment team and are looking for a 100% remote Senior Risk Adjustment Coding Specialist. This role will be the lead/point person for the whole team. What's needed is ability to lead projects, and drive projects on their own. Not someone who needs to be given tasks or work each day. The role will be guiding other team members with the project work. Summary: Essentially, this is a coder/auditor role. The candidate w

Global Labeling Product Leader

Sunrise Systems, Inc.

Remote

Contract

Sunrise System Inc. is currently looking for Global Labeling Product Leader, Remote with one of our top client. Job Title: Global Labeling Product Leader Location: Remote Duration: 6 months Position Type: Hourly contract Position (W2 only) 100% REMOTE Summary Of Role Contractor Global Labeling Product Leader (GLPL) to support Pharma products in Janssen R&D, within Global Labeling.Responsibilities include the development of target labeling, and managing the development of updates to Company Cor