Job Description
We’re Hiring!
Our key client in clinical robotics is looking for additional members for their team. We have a Regulatory Standards Management (RSM) Specialist on the team.
Rate : $40.00-$50.00 / hour on W2
Work Type : Onsite - Sunnyvale, CA 94086
Duration : 12-month contract (with possible extension)
Job Overview :
- The Regulatory Standards Management (RSM) Specialist works closely with the RSM Manager and team to surveil, assess, and integrate Standards and Regulations applicable to the clients.
- The Specialist maintains process documentation and logs and generates reports to help internalize global regulations and meet compliance targets for completion of Regulatory Surveillance Assessments and integration hand-off activities.
- The RSM Specialist is responsible for executing activities associated with the client’s RSM Process and other company procedures to create and maintain records and logs for Regulatory Surveillance processes as follows.
Key Responsibilities :
Create purchase orders.Requests translations through internal processes as needed.Reviews Regulatory Surveillance Records (RSRs) for complete justifications and on-time delivery.Tracks surveillance records through the initiation, triage, and approval process.Provide support to cross-functional teams to input information into TrackWise.Maintains and completes requests for standards.Maintains publications per DOP, Process for External Standards Library.Initiates External Standards Forms in Agile (ACCS) as needed.Liaises SME and RA to facilitate completion of assessments.Review completed assessments for completeness and accuracy.Confirms RSA assignments with SME.Negotiates RSA due dates and extensions.Provides reminders and status updates upon request.Assists individuals in acquiring access to the RSM TrackWise application.RSM Specialist will support internal and external Quality System audits and will report relevant information periodically.Other activities as identified by RSM management.Qualifications :
Bachelor's or higher or equivalent work experience required.Familiarity with quality management systems, such as ISO 9001 and ISO 13485.Computer literacy (PC, Microsoft Word / Excel / PowerPoint, Access, Outlook), experience with TrackWise and Agile PLM a plus.Facility with Smartsheet, MS-EXCEL charts and data functions (Filter, Sort, COUNTIFS), MS-WORDFacility with Agile or similar Automated Change Control System (Search and monitor workflows of existing change orders.The ability to create change orders (completing the title page, uploading documents, and running the approval matrix) is a plus.Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices including analytical problem-solving.Demonstrated organizational and planning skills, including action-oriented focused urgency, and driving for results.Strong interpersonal skills, ability to work with others in a team environment, effective interactions in cross-department teams.Strong Project management skills (e.g., administrative, WBS, and record-keeping)Ability to be effective in complex projects with ambiguity and / or rapid change.Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.Detail-orientated, with emphasis on accuracy and completeness.Strong written and oral communication skills.Raise PBC is committed to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religious creed, national origin, ancestry, age, disability, genetics, gender identity, veterans' status, sexual orientation, or any other characteristic protected by law. Raise PBC is an equal-opportunity employer encouraging diversity in the workplace.
USVM
Salary : $40 - $50
