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Regulatory Affairs Analyst(Usc/gc Only)

3 months ago

Irvine, United States Infosoft Teksolutions Full time

Here are the job position details for your review:
Job Title**:Regulatory Affairs Analyst (USC/GC Only & W2 ONLY)**
Pay Rate**:$50 to $55/HR**
Duration**:9 months**
Location**:Irvine, CA (Onsite)**

**Shift: 8 am to 5 pm.**

We are looking for a **Regulatory Affairs Analyst** to complete and maintain regulatory approvals and clearances of assigned products.
- Create **regulatory submissions **(exercising judgment to protect proprietary information) for finalization and submission by **OUS **affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
- Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on **regulatory requirements,** including presenting alternatives for meeting regulatory requirements resolving conflicts between those requirements and development issues, and/or reporting to management.

**Requirements**:

- Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
- 3-5 years of **regulatory affairs** or related experience in a medical device, pharma, or a related industry. **International regulatory affairs **experience is desired
- Excel spreadsheet
- Design history files experience is desired.
- Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

**Job Type**: Contract

Pay: $50.00 - $55.00 per hour

Expected hours: 40 per week

Experience level:

- 3 years

Schedule:

- 8 hour shift

Ability to Commute:

- Irvine, CA 92614 (required)

Ability to Relocate:

- Irvine, CA 92614: Relocate before starting work (required)

Work Location: In person