47 Sr.Regulatory Affairs Jobs in Irvine, CA
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Kelly Science, Engineering, Technology & Telecom
Irvine, CA | Full Time
$110k-141k (estimate)
1 Month Ago
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Sr.Regulatory Affairs
$99k-126k (estimate)
Full Time | Business Services
3 Weeks Ago
intellectt is Hiring a Sr.Regulatory Affairs Near Irvine, CA
Role: Sr Spec, Regulatory AffairsLocation: Irvine, CA - 92606Duration: 9 Months Education And Experience
- Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
- 5-7 years of experience required
- The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.
- 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$99k-126k (estimate)
POST DATE
06/05/2024
EXPIRATION DATE
07/06/2024
WEBSITE
intellectt.com
HEADQUARTERS
ISELIN, NJ
SIZE
200 - 500
FOUNDED
2018
CEO
KIRAN MADALA
REVENUE
$5M - $10M
INDUSTRY
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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