Coord 3, Regulatory Affairs

Lancesoft

Irvine, CA

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JOB DETAILS

SALARY

$50

SKILLS

Analysis Skills, Biology, Biomedical Engineering, Communication Skills, Cross-Functional, Detail Oriented, Document Management, FDA (Food and Drug Administration), Government, Interpersonal Skills, Maintain Compliance, Medical Equipment, Microsoft Office, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Lifecycle, Public/Media/Press/Analyst Relations, Regulations, Regulatory Requirements, Regulatory Submissions, Seminars, Team Player, Technical Writing, Writing Skills

LOCATION

Irvine, CA

POSTED

1 day ago

The Regulatory Affairs Coordinator III independently supports and executes regulatory activities for U.S. Class II and EU Class II & Class III medical devices across the product lifecycle. This role prepares and maintains regulatory submissions and technical documentation, ensures ongoing compliance with FDA and EU MDR requirements, and serves as a regulatory partner to cross-functional teams. This role (Coordinator III) is hybrid (remote/in-office) and works with limited supervision.
Education

Bachelor s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field

Experience

5-7 years of Regulatory Affairs experience in the medical device industry
Direct experience supporting Class II medical devices in the U.S. And Class II and/or Class III medical devices EU
Hands on involvement with EU MDR technical files

Shift: [' Ability to manage competing priorities in a fast-paced environment Attention to detail Good problem-solving, organizational, analytical and critical thinking skills Good written and verbal communication skills and interpersonal relationship skills Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)']

Start: [' Proficiency in document management systems and Microsoft Office 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 Demonstrate a strong willingness to learn new processes, tools, and technologies. Follow guidance, ask questions, and training to develop role specific skills. 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 Coursework, seminars, and/or other formal government and/or trade association training required']

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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