regulatory Jobs in San Jose, CA

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Regulatory Affairs Senior Manager - Vascular (on-site)

Abbott Laboratories

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 Associate

Apex Systems

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

Regulatory Affairs Professional

Cygnus Professionals

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)

Sr. Regulatory Affairs Specialist

APN Software Services, Inc

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, APAC

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

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

Contract - Financial Business Analyst with Regulatory Reporting Experience

DATASYS CONSULTING & SOFTWARE INC

Remote

Full-time

JOB DESCRIPTION: CONTRACT ON W2 (NO C2C) Title: Financial Business Analyst with Regulatory Reporting Experience Location: New Jersey Work Mode: Remote We are seeking a highly skilled and motivated Financial Analyst specializing in regulatory reporting to join the team. The ideal candidate will have a strong understanding of financial principles, regulatory requirements, and reporting standards. The role involves analyzing financial data, ensuring compliance with regulatory guidelines, and provid

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

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.

Technical Writer with ISO Compliance Regulatory experience

BayOne Solutions

Remote

Contract

Technical Writer Location: Remote work Duration: 7 months Job description: We are seeking a Technical Writer to join our team and support the IT Operations project tracks within the ISO initiative. In this role, you will collaborate closely with the IT Ops project management team to conduct working sessions and engage with external stakeholders across various ISO tracks. The immediate focus of this position is to work collaboratively with the Infrastructure and Technology, IT Business Engagement