regulatory affairs manager Jobs in santa clara, ca

1 - 8 of 8 Jobs

Regulatory Affairs Senior Manager - Vascular (on-site)Job Title - Regulatory Affairs Senior Manager - Vascular (on-site)

Abbott LaboratoriesCompany Name - Abbott Laboratories

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Santa Clara, California, 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

Regulatory Affairs ProfessionalJob Title - Regulatory Affairs Professional

Cygnus ProfessionalsCompany Name - Cygnus Professionals

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Palo Alto, California, USA

Contract

Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches Product Registration Experience: Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical filesKnowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k)

Regulatory AffairsJob Title - Regulatory Affairs

Judge Group, Inc.Company Name - Judge Group, Inc.

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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

Regulatory Affairs AssociateJob Title - Regulatory Affairs Associate

Apex SystemsCompany Name - 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

Sr. Regulatory Affairs SpecialistJob Title - Sr. Regulatory Affairs Specialist

APN Software Services, IncCompany Name - APN Software Services, Inc

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Palo Alto, California, USA

Contract

Please contact Abdul on "" OR email me at "" *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 submissions. *Recommend strategies for earliest possible approvals for marketing applications * Performs regulatory projects or acts as a member of the project steering group. * Submits required documentat

Content Policy Manager, Regulatory Compliance, APACJob Title - Content Policy Manager, Regulatory Compliance, APAC

Meta Platforms, Inc. (f/k/a Facebook, Inc.)Company Name - Meta Platforms, Inc. (f/k/a Facebook, Inc.)

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Menlo Park, California, USA

Full-time

Meta Platforms, Inc. (f/k/a Facebook, Inc.) has the following position in Menlo Park, CA: Content Policy Manager, Regulatory Compliance, APAC: Develop and refine principles and policies related to regulatory compliance with takedown requests, with a special focus on compliance policies and regulatory escalations from the APAC region. (ref. code REQ-2404-135554: $189,233 - $204,820). Individual pay is determined by skills, qualifications, experience, and location. Compensation details listed in

Regulatory Affairs Specialist IIIJob Title - Regulatory Affairs Specialist III

Fusion Life SciencesCompany Name - Fusion Life Sciences

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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

Senior Regulatory Affairs Specialist (Medical Devices)Job Title - Senior Regulatory Affairs Specialist (Medical Devices)

ApTaskCompany Name - ApTask

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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.