Regulatory Affairs Strategy Associate


Redrouthu's Inc
Dice Job Match Score™
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Job Details
Skills
- Reporting
- Regulatory Affairs
- Facilitation
- S-PLUS
- English
- Medical Devices
- Pharmaceutics
- GxP
- Standard Operating Procedure
- Documentation
- Quality Control
- Training
- Regulatory Compliance
- SANS
Summary
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
- Dice Id: 91174039
- Position Id: OOJ - 1079-80-1787673100
- Posted 8 days ago
Company Info
About Redrouthu's Inc
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.
- Permanent Hires: Identifying and embedding permanent talent that matches your company's technical standards and internal culture.
- Contract Staffing: Rapidly deploying heavily-screened contract professionals to meet immediate project timelines and fluctuating workloads.
- On-Demand RPO: Embedding our elite recruitment specialists directly into your ecosystem to manage talent acquisition at any scale.
- India Talent Solutions: Utilizing our deep on-the-ground expertise to help US firms build, transition, and manage highly effective technical teams within the Indian market.
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.
- Custom Software Engineering: Translating your complex business logic into custom, cloud-native digital assets mapped precisely to your workflows.
- Managed IT Services: Taking full ownership of daily IT operations, security protocols, and infrastructure efficiency so your internal teams can remain focused on core milestones.
- Managed Projects (SOW): Fully managing end-to-end technical deliverables under clear Statement of Work (SOW) frameworks, deploying specialized tech experts to hit your exact goals.
Why Technologists Choose Redrouthu’s
For developers, engineers, and IT professionals, Redrouthu’s is more than an agency. It is a career accelerator.
- Impactful Projects: We place talent in roles across dynamic industries, including Finance, Healthcare, Retail, and Manufacturing.
- Diverse Technical Ecosystems: Our placements and projects span a massive technical spectrum, from developers and QA specialists to Cloud Engineers and Data Architects.
- Clarity First: We do not ghost candidates or send them into ambiguous interview loops. We ensure you have extreme clarity regarding project scope, expectations, and compensation from day one.
Our Mission & Vision
- Mission: To empower global organizations to execute their digital strategies with absolute confidence by delivering the exact talent and robust technical infrastructure they need.
- Vision: To serve as a globally recognized unified partner where people, process, and modern technology converge to unlock operational excellence and sustained business growth.
Core Values We Live By
- Outcome Over Activity: We do not count hours or measure success by volume. We measure it exclusively by successful placements, stable system uptimes, and realized business value.
- Accountability & Trust: We stand behind the software we build and the technical candidates we place.
- Simplicity & Speed: We avoid unnecessary corporate jargon and technical complexity, choosing instead to deliver streamlined, high-speed execution.

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