
Redrouthu's Inc
Lake Forest, California • Today
Easy Apply
Full-time
Compensation information provided in the description
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Redrouthu's Inc
Lake Forest, California • Today
Easy Apply
Full-time
Compensation information provided in the description






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Regulatory Affairs Strategy Associate
Location: Lake Forest, CA Onsite 5 days
Exp: 7+ Years
Salary: $110k-$115K Salary
Sample Profile Attached
Medical Device Domain Exposure
Job Description:
The Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for the regulatory strategy, ensuring local product registration and facilitating health registration approvals.
Required:
7 Years of Relevant Experience
Bachelor s Degree or Equivalent years of directly related experience (or high school +7 yrs; Assoc.+5 yrs; M.S.+3 yrs)
The ability to fluently read, write, understand and communicate in English
Expectations / Responsibilities:
A self-starter, assertive, who will be the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvals
Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations
Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
Meet individual job requirements and contribute to the overall compliance of the organization
Redrouthu's is a premier, dual-capability talent and technology partner dedicated to helping organizations scale with confidence. We bridge the critical gap between complex business needs and flawless execution by delivering top-tier technical talent and engineering resilient, scalable IT solutions.
We do not believe in a "one-size-fits-all" mentality. Whether an organization requires urgent contract staffing, strategic full-time hires, or custom software architecture built from scratch, Redrouthu’s operates as a dependable extension of our clients' teams. With offices in Austin, Texas, and robust operational capabilities in India, we seamlessly support domestic scaling and international talent expansion.
What We Do: Core Pillars
1. Tech & Engineering Talent Solutions
Hiring often breaks down when recruiters prioritize resume volume over contextual alignment. At Redrouthu's, we focus deeply on quality and precision hiring. We spend time understanding the explicit role requirements, team challenges, and long-term delivery timelines before presenting a single profile.
2. Systems & Custom IT Solutions
We engineer adaptive ecosystems and scalable software architectures built to support evolving business growth. We prioritize clean structure, data security, and long-term maintainability over superficial, rushed deliveries.
Why Technologists Choose Redrouthu’s
For developers, engineers, and IT professionals, Redrouthu’s is more than an agency. It is a career accelerator.
Our Mission & Vision
Core Values We Live By
🔢 Crunching numbers...
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