16 Professional - Sr Spec, Regulatory Affairs Jobs in Irvine, CA
Trinus Corporation is Hiring a Professional - Sr Spec, Regulatory Affairs Near Irvine, CA
The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.
Key Responsibilities
- Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
- Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
- Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
- Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.
- Other incidental duties assigned by Leadership.
- Coursework, seminars, and/or other formal government and/or trade association training required
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
- Good written and verbal communication skills and interpersonal relationship skills
- Good problem-solving, organizational, analytical and critical thinking skills
- Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
- Solid knowledge and understanding of global regulatory requirements for new products or product changes.
- Solid knowledge of new product development systems
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- Ability to build productive internal/external working relationships
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
- Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
- 5-7 years of experience required
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Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE/MBE/SBE/SDB firm accredited by WBENC, NMSDC, and SBA.
Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.
At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.
To learn more about us, please visit our website www.trinus.com
Job Summary
Full Time
IT Outsourcing & Consulting
$91k-117k (estimate)
06/05/2024
08/27/2024
trinus.com
ARCADIA, CA
25 - 50
1995
SANJAY KUCHERIA
$5M - $10M
IT Outsourcing & Consulting
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About Trinus Corporation
In the digital world, Trinus Corporation has managed to develop and offer solutions and consulting services in data management, data analytics, and data security. Trinus is an IT consulting firm that helps its clients manage, access, and analyze data. Since 1995, we have worked with companies of all sizes and across industries to deliver business-aligned solutions along operational, tactical and strategic dimensions for driving revenue growth and operational efficiency. Our focus lies in Data Integration, Data Migration, Data Quality, Master Data Management, Data Governance, Data Warehousing, ...Data Lakes, Reporting, Dashboards, Visualization, Analytics, IoT, AI, Machine Learning, Blockchain & IT Security.
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