senior regulatory affairs associate Jobs in edison, nj

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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.

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

Senior Director, Global Regulatory Leader, CAR-T Therapy

Johnson & Johnson

Raritan, New Jersey, USA

Full-time

Description Johnson & Johnson is currently seeking a Senior Director, Global Regulatory Leader for transformational chimeric antigen receptor T (CAR-T) cell products within the Oncology Therapeutic Area portfolio. This position can be located either in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, England. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex

Regulatory Affairs Specialist III

Fusion Life Sciences

Remote

Contract

Job Title: Regulatory Affairs Specialist (Remote) Summary: Seeking a fluent French speaker to guide EU MDR project teams. Responsible for preparing and submitting EU MDR documentation for medical devices (Class , IIa, IIb, I sterile or reusable) for CE marking and EU commercial release. Collaborate with cross-functional teams and Notified Bodies. Supervision: Reports to Sr. Manager or Director of Regulatory Affairs. No supervisory responsibilities. Essential Duties: Ensure EU MDR compliance for

Sr. Counsel, Business & Legal Affairs

NBC Universal

New York, New York, USA

Full-time

Company Description We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our theme parks and consumer experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, MSNBC, CNBC, NBC Sports, Telemundo, NBC Local Stations, Bravo, USA Network, and Peacock, our premium ad-supported streaming service. We produce and distribute premier filmed entertainment and programming through Universa

Regulatory/ Pharmacovigilance Associate (REMOTE)

NetSource, Inc.

Remote

Contract

Please note that this is a 1 year contract position. HIGHLIGHTED SKILLS: - Role can be 100% REMOTE - May travel for a possible mandatory meeting onsite (Raritan, NJ) for 1-2 days, not very often at all - Bachelors Degree required - Pharmacovigilance experience needed - Must be flexible / adaptive - Must be able to problem solve, and know when to ask for help - Working within the Global Environment / Global Teams - Regulatory Affairs experience - MAIN ASPECT OF ROLE: Support Aggregate Tracking p

Sr Data Analyst - Non-Financial Regulatory Reporting

Bank Of America

New York, New York, USA

Full-time

This role will serve as a AMRS Regulatory Reporting Manager responsible for driving key reporting activities and functions within the Global Markets NFRR team. Required Skills : Bachelor's Degree with minimum 5+ years of Banking experience; Professional qualifications (CPA) preferred Global Markets, Risk/Compliance Operations and regulatory reporting experience Ability to provide clear oral and written communication to a variety of business and technical audiences. Regulatory Reporting and anal

CARI - Data Domain Architect - Senior Associate

JPMorgan Chase & Co.

Jersey City, New Jersey, USA

Full-time

Are you a skilled data professional with a passion to transform raw data into actionable insights, and a demonstrated history of learning and implementing new technologies? The Finance Data & Insights Team is an agile product team responsible for the development, production, and transformation of Financial data and reporting across Consumer and Community Banking (CCB). Our vision is to improve the lives of our people and increase value to the firm by leveraging the power of our data and the best

Senior Associate, Cybersecurity Assessment Maturity Analyst

Capital One

New York, New York, USA

Full-time

Center 3 (19075), United States of America, McLean, Virginia Senior Associate, Cybersecurity Assessment Maturity Analyst The role of Cybersecurity Assessment Maturity Analyst sits within the Cyber Governance, Risk, and Compliance (GRC) organization supporting our enterprise Cyber Assessment Maturity Program. The Cybersecurity Assessment Maturity Analyst will support several large annual regulatory cyber assessments as well as help our team to compile operational information, perform SME interv

Senior Associate, Endpoint Security Engineer

Capital One

New York, New York, USA

Full-time

Center 3 (19075), United States of America, McLean, Virginia Senior Associate, Endpoint Security Engineer Do you love building and pioneering in the technology space? Do you enjoy solving complex technical problems in a fast-paced, collaborative, inclusive, and iterative delivery environment? At Capital One, you'll be part of a big group of makers, breakers, doers and disruptors, who love to solve real problems and meet real customer needs. General Responsibilities: Work with product owners t

Senior Data Engineer - Principal Associate

Capital One

New York, New York, USA

Full-time

802 Delaware Avenue (18052), United States of America, Wilmington, Delaware Senior Data Engineer - Principal Associate Do you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative,inclusive, and iterative delivery environment? At Capital One, you'll be part of a big group of makers, breakers, doers and disruptors, who solve real problems and meet real customer needs. We are seeking Data Engineers who are passionate a

Senior Data Engineer - Principal Associate

Capital One

New York, New York, USA

Full-time

802 Delaware Avenue (18052), United States of America, Wilmington, Delaware Senior Data Engineer - Principal Associate Do you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative,inclusive, and iterative delivery environment? At Capital One, you'll be part of a big group of makers, breakers, doers and disruptors, who solve real problems and meet real customer needs. We are seeking Data Engineers who are passionate

Senior Data Engineer - Principal Associate

Capital One

New York, New York, USA

Full-time

Center 2 (19050), United States of America, McLean, Virginia Senior Data Engineer - Principal Associate Do you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative,inclusive, and iterative delivery environment? At Capital One, you'll be part of a big group of makers, breakers, doers and disruptors, who solve real problems and meet real customer needs. We are seeking Data Engineers who are passionate about marrying d

Smart Factory Senior Associate

Pfizer

New York, New York, USA

Full-time

ROLE SUMMARY The Digital Manufacturing Team is responsible for the delivery of Pfizer's Core Digital Manufacturing Operations Management (MoM) capabilities at every level of the Pfizer Global Supply (PGS) Plant Network (ISA 95 Levels 0-4). These solutions are critical to Manufacturing & Lab Execution, Manufacturing Process Intelligence and Production Optimization that aim to improve product quality, increase asset utilization/uptime, automate manual workflows, and streamline plant floor operati

Assistant Network/Security Engineer (IT Senior Associate Level 2)

CUNY Central Office

New York, New York, USA

Full-time

Job Title: Assistant Network/Security Engineer (IT Senior Associate Level 2) CUNY TV, the City University of New York's television station seeks to hire an Assistant Network Security Engineer. Reporting to the CUNY TV CIO, the Assistant Network Security Engineer will be responsible for network security including, but not limited to, security policies on Palo Alto and Cisco-Meraki firewalls, port security on switches and physical security with S2 system. Key duties and responsibilities include

Senior Associate, Strategy & Operations

Headway

New York, New York, USA

Full-time

Headway's mission is a big one - to build a new mental health care system everyone can access. We've built technology that helps people find great therapists with the first software-enabled national network of providers accepting insurance. 1 in 4 people in the US have a treatable mental health condition, but the majority of providers don't accept insurance, making therapy too expensive for most people. Headway is building a new mental healthcare system that everyone can access by making it easy

(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, Clinical Quality Review

Headway

New York, New York, USA

Full-time

Headway's mission is a big one - to build a new mental health care system everyone can access. We've built technology that helps people find great therapists with the first software-enabled national network of providers accepting insurance. 1 in 4 people in the US have a treatable mental health condition, but the majority of providers don't accept insurance, making therapy too expensive for most people. Headway is building a new mental healthcare system that everyone can access by making it easy

Senior Associate, Clinical Quality Education

Headway

New York, New York, USA

Full-time

Headway's mission is a big one - to build a new mental health care system everyone can access. We've built technology that helps people find great therapists with the first software-enabled national network of providers accepting insurance. 1 in 4 people in the US have a treatable mental health condition, but the majority of providers don't accept insurance, making therapy too expensive for most people. Headway is building a new mental healthcare system that everyone can access by making it easy