Regulatory Affairs Specialist(W2 Only)

3 weeks ago


Palo Alto, United States Infosoft Teksolutions Full time

Here are the job position details for your review:
Job Title**:Regulatory Affairs Specialist (W2 Only)**
Pay Rate**:$63 to $68.89/HR**
Duration**:12 months**
Location**:Palo Alto, CA (Hybrid - 2 days/week onsite)**

**Must have skills on the Resume**:

- **Product Registration Experience**:
We are looking for a **Regulatory Affairs Specialist.**
- Perform the coordination and preparation of **regulatory submissions** for brachytherapy devices and software devices according to regulatory requirements
- Identifies, analyzes, and implements country-specific requirements necessary for **product-related submissions.**:

- Submits required documentation/information to local authorities or our internal.
- Write and maintain submission procedures, work instructions, and templates relevant to regulatory compliance.
- Performs review of promotional material for regulatory compliance according to country-specific requirements.

**Experience**:

- 5-8 years of regulatory affairs relate experience
- **Product Registration Experience**:

- Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications, and EU MDR technical files.
- Knowledge of regulatory guidance documents (**FDA, Health Canada, EU MDR**) for determining if a product change requires a regulatory submission (software and hardware devices).
- Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1 as evidenced by coursework or submissions that required the use of each standard
- Teamwork and collaboration:

- Proficient in utilizing business tools such as E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.

**Job Type**: Contract

Pay: $63.00 - $68.89 per hour

Expected hours: 40 per week

Experience level:

- 5 years

Schedule:

- 8 hour shift
- Monday to Friday

Ability to Commute:

- Palo Alto, CA 94304 (required)

Ability to Relocate:

- Palo Alto, CA 94304: Relocate before starting work (required)

Work Location: In person



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