Senior Regulatory Affairs Specialist Jobs

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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.
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Posted 17 hours ago | Updated 1 hour ago

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.
Posted 1 day ago | Updated 3 hours ago

Senior Regulatory Affairs

Thermo Fisher Scientific

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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
Posted 14 days ago | Updated 4 hours ago

Regulatory Affairs Specialist III

Thermo Fisher Scientific

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Asheville, North Carolina, USA

Full-time

Job Description Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a st
Posted 14 days ago | Updated 4 hours ago

Regulatory Affairs Specialist

Ledgent Technology

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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
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Posted 7 days ago | Updated 2 hours ago

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
Posted 1 day ago | Updated 3 hours ago

Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.

Johnson & Johnson

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Cincinnati, Ohio, USA

Full-time

Description Robotics & Digital Solutions, part of the Johnson & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Specialist . The preferred location for this role is within a commutable distance of Cincinnati, OH however candidates within commutable distance of Santa Clara, CA or Raritan, NJ will also be considered . This role will work a Flex/Hybrid schedule with 3 days per week on-site. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our
Posted 6 days ago | Updated 4 hours ago

Senior Regulatory Affairs Program Lead

Johnson & Johnson

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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
Posted 10 days ago | Updated 4 hours ago

Regulatory Affairs Manager - Electrophysiology

Abbott Laboratories

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Plymouth, Minnesota, USA

Full-time

Abbott is a global healthcare leader 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 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 7 days ago | Updated 1 day ago

Manager Regulatory Affairs

Abbott Laboratories

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Des Plaines, Illinois, USA

Full-time

Abbott is a global healthcare leader 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 114,000 colleagues serve people in more than 160 countries. About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future
Posted 7 days ago | Updated 1 day ago

CMC 2 Regulatory affairs

Hectadata LLC

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Jersey City, New Jersey, USA

Contract, Third Party

Greetings from Hectadata, LLC. We are hiring for the position of CMC 2 Regulatory affairs Please find the below Job Description. If you are interested in this position, kindly submit your applications via Dice. Job Title: CMC 2 Regulatory affairs Location: JFK Parkway, NJ Job Description: We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with
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Posted 9 days ago | Updated 9 days ago

Regulatory Affairs Associate

Apex Systems

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Mountain View, California, USA

Full-time

Job#: 2027155 Job Description: Client: IRIDEX Position: Regulatory Affairs Associate Location: Mountain View, CA Estimated Duration: The client approximates that this project may last up to 5 months. However, there is no guarantee of employment for any length of time. Pay Rate Range: $35 - $45/hr IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, Health Cana
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Posted 1 day ago | Updated 6 hours ago

Regulatory Affairs Manager - Structural Heart (on-site)

Abbott Laboratories

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Saint Paul, Minnesota, USA

Full-time

Abbott is a global healthcare leader 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 114,000 colleagues serve people in more than 160 countries. About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future
Posted 7 days ago | Updated 15 hours ago

Regulatory Affairs Consultant

Stellar Consulting Solutions

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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
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Posted 38 days ago | Updated 17 hours ago

Sr. Regulatory Operations Specialist

Zachary Piper Solutions, LLC

•

Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop content plans for IND & CTA dossiers. Lead interactions with external publishing teams to compile IND or CTA submissions, including reports and
Posted 1 day ago | Updated 3 hours ago

Senior Web Production Specialist

Randstad Digital

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Los Angeles, California, USA

Contract

job summary: Our cleint, a global leader in the investment management industry, has an immediate long term contract role for a Senior Web Production Specialist. This position will be onsite in downtown Los Angeles or in Irvine, California three days a week. We are seeking digital product specialists with hands on experience using Adobe Experience Platform (AEP) including Adobe Real-Time Customer Data Platform (RT-CDP), Adobe Journey Optimizer (AJO), and Adobe Customer Journey Analytics (CJA).
Posted 2 days ago | Updated 2 hours ago

Engineering Sr. Specialist

Randstad Digital

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Rochester, New York, USA

Contract

job summary: Description: The Sr. Specialist will require a solid understanding of electronics and mechanical concepts. This position will also require participating in a team environment. Routinely interacts with design engineers, manufacturing staff, management and planning. Requires the application of the principles and techniques of electrical/mechanical engineering. The successful candidate will be responsible for the board level modifications, troubleshooting and testing, repairing of ha
Posted 7 days ago | Updated moments ago

Sr. PKI Info Security Specialist (Hybrid)

Dexian DISYS

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Plano, Texas, USA

Full-time

Position: PKI Info Security Specialist Locations: Plano, TX; Camus, WA; Palo Alto, CA; OR Tampa, FL Duration: Direct Hire Definitions: PKI: Public Key Infrastructure A set of tools and processes to manage cryptographic keys that encrypt any communication on web browsers (a.k.a. making sure data shared over the internet is secured). Cryptography: Hides or codes information so that only the sender and intended recipient can view or decrypt its contents Key Management Service (KMS): System for se
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Posted 1 day ago | Updated 2 hours ago

Senior Specialist Quality Assurance - Level II (Associate)

Pyramid Consulting, Inc.

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Gwynedd, Pennsylvania, USA

Contract

Immediate need for a talented Senior Specialist Quality Assurance - Level II (Associate). This is a 06+ Months contract opportunity with long-term potential and is located in Lower Gwynedd Township, PA, (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 24-20481 Pay Range: $25 - $32/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).
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Posted 10 days ago

Senior Trade Support Specialist/Analyst

Dexian Signature Consultants

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New York, New York, USA

Contract

Job Summary: Dexian is seeking a Senior Trade Support Specialist / Analyst for an opportunity with a client located in New York, NY. Responsibilities: Provide Application Support for multiple Equity Sales and Trading Applications focusing on Bloomberg and Fidessa/OMS Provide front office and operational support to traders across various regions Support trading platforms during high paced production trading scenarios Be able to quickly analyze and manage incidents in production environments and
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Posted 9 days ago | Updated 2 hours ago