regulatory Jobs in San Jose, CA

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Regulatory Affairs

Judge Group, Inc.

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

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

Regulatory Reporting Oversight Manager

eBay

San Jose, California, USA

Full-time

At eBay, we're more than a global ecommerce leader - we're changing the way the world shops and sells. Our platform empowers millions of buyers and sellers in more than 190 markets around the world. We're committed to pushing boundaries and leaving our mark as we reinvent the future of ecommerce for enthusiasts. Our customers are our compass, authenticity thrives, bold ideas are welcome, and everyone can bring their unique selves to work - every day. We're in this together, sustaining the futur

CMC 2 Regulatory affairs

HUMAC INC.

Remote

Third Party, Contract

Role: CMC 2 Regulatory affairs Location: Remote Duration: Long-Term Job Description: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member StatesManage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports an

CMC Regulatory Affairs Manager

TechSpace Solutions Inc.

Remote

Contract, Third Party

Job Title : CMC Regulatory Affairs Manager Location : Remote Duration : 12 Months Responsibilities: Leading project teams, ensuring maintenance of team records and process-related documentation i.e., process maps, job aids, project trackers, checklists, etc.Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for

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.

Principal Regulatory Affairs Specialist (Remote)

Medtronic

Remote or Los Angeles, California, USA

Full-time

Careers that Change Lives Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's w

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

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