Regulatory Affairs Strategy Associate (cur_1_125027@curatelyai.net)

Job Description

Job Description

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Regulatory Affairs Strategy Associate

Location: Lake Forest, CA - ONSITE

Contract Length: 6 months with potential to extend

Pay Rate : $40 - $57/hr.  On W2 (depending on experience)

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.

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

Skill Required:

• 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
• 7 Years of Relevant Experience

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.