This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at +1(732)-276-2791
Role: Sr Regulatory Affairs Specialist
Location: Irvine, CA - 92606
Duration: 9 Months
Summary
Job Description:
The primary role of a Regulatory Affairs Specialist is to obtain and maintain regulatory approvals and clearances for assigned products.
Key Responsibilities
Prepare regulatory submissions for review and submission by international affiliates; manage timelines and track progress, contribute to regulatory strategy development, and align submissions with country-specific requirements.
Provide guidance on strategies and contingency planning for international regulatory requirements, assess the impact of global regulations, and suggest ways to expedite approvals.
Represent the regulatory function on manufacturing and product development teams, offering input on regulatory requirements and presenting alternatives to meet these requirements.
Advise business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review labeling content. Provide guidance on process improvement projects based on experience and feedback from affiliates.
Perform other duties as assigned by leadership.
Additional Skills
Training through coursework, seminars, or trade associations is required.
Expertise in Microsoft Office Suite (Word, PowerPoint, Excel).
Comprehensive understanding of global regulations for medical devices (Class II and/or Class III).
Knowledge of regulatory requirements for new products or product changes.
Teamwork skills, including working with inter-departmental teams and representing the organization on projects.
Ability to build productive internal and external relationships.
Adherence to EHS rules and preventive measures for injury and pollution control.
Education And Experience
Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or equivalent.
5-7 years of relevant experience required.
Seniority level
Associate
Employment type
Contract
Job function
Legal
Industries
Medical Equipment Manufacturing
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