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
SAP Revenue/Production Accounting/Regulatory Reporting Consultant (Oil & Gas) Location: Houston, TX/Argentina/Brazil (for workshops)+ (Travel expenses) Duration: ASAP to 12/13/2024 with the possibility of an extension Job Description: 1) Revenue Accounting and Disbursement 2) Production Accounting :Gas Booking and contracting, allocation, Well level accounting for production 3) Regulatory Reporting govt and federal agency including annual reporting.
SAP PRA Consultant (Regulatory Reporting ) Occasional Travel to Houston TX (Argentina, Brazil) Job Description: 1) Revenue Accounting and Disbursement 2) Production Accounting :Gas Booking and contracting, allocation, Well level accounting for production 3) Regulatory Reporting govt and federal agency including annual reporting.
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
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 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
