Regulatory Affairs Specialist
Pentangle Tech Services
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Job Details
Skills
- Medical Devices
- Regulatory Affairs
- Quality Control
- Standard Operating Procedure
- Pharmaceutics
Summary
Job title: Regulatory Affairs Strategy Associate
Location: Lake Forest, CA
Duration: Permanent
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.
WHAT YOU’LL BRING :
• Bachelor’s Degree or Equivalent years of directly related experience (or high school +7 yrs; Assoc.+5 yrs; M.S.+3 yrs)
• 7 Years of Relevant Experience
• The ability to fluently read, write, understand and communicate in
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: 91161410
- Position Id: 9053597
- Posted 5 days ago
Company Info
About Pentangle Tech Services
Pentangle Tech Services is the fastest-growing Engineering Services Firm.
Our Core Services include -
➡️ Recruitment Services
➡️ Recruitment Process Outsourcing (RPO)
➡️ Engineering Training
➡️ Projects Implementation and
➡️ Talent Management to top-tier organizations looking for mid to senior-level professionals.
Our global reach and world-class assessment tools enable us to harness the extensive network of trained
professionals both locally and globally.
Pentangle Tech Services is a talent solution company that focuses on empowering our clients with the best possible talent in a diverse range of industries. As a specialist in recruitment, we know how to find the best people for hard-to-fill roles, and we do it quickly and effectively.
Pentangle Tech is also the one-stop solution for various Engineering industries. We offer concepts to commercialization solutions in the field of Automotive, Embedded, and Software Technologies.
The dedicated team provides the following solutions:
In-Vehicle Infotainment,
Active Safety and OTA,
Cyber security,
Programmable Logic Design and Board Design,
Application Software Development with complete product life cycle development and more.
Pentangle Tech helps clients to increase efficiency, improve quality management and train a qualified
servicing team. The Center has so far signed several training agreements with reputed automotive OEMs.
Contact us today to resolve your automotive needs and to jumpstart your journey with our unparalleled recruitment services.
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