LanceSoft, Inc. ยท 3 weeks ago
Regulatory Affairs Coord 3
Irvine, CA
Full-time, Contract
Hybrid
Senior Level
$65/hr - $70.86/hr
5+ years expLanceSoft, Inc. is a company seeking a Regulatory Affairs Coordinator. The role involves supporting US and EU regulatory submissions, developing regulatory strategies, and collaborating with business units on registration requirements.
Information Technology
Responsibilities
Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements
Participate in assessing and collating regulatory impact and developing regulatory strategy
Collaborate and approve change requests/change notifications
Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content
Other incidental duties assigned by Leadership
Qualification
Required
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
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
Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
5-7 years of experience required
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase