Regulatory Affairs Specialist-4694

2 weeks ago

Palo Alto, United States Infosoft Full time

One of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.

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

This position is for the **Healthcare Diagnostics **division.

We are looking for **Sr. 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.**:

- Performs regulatory projects or acts as a member of the project steering group.
- Submits required documentation/information to local authorities or our internal.
- Initiates and escalates necessary activities if deviations are identified.
- Ensures the creation of adequate documentation for audits/inspections.
- Performs training within the organization in country-specific regulatory requirements, if applicable.
- 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.
- Is expected to adopt existing concepts, methodologies, etc. to create and open up new ways of approaching and fulfilling specific internal and external client requests or project 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:

- Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
- Proficient in utilizing business tools such as E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.

**Job Type**: Contract

Pay: $60.00 - $68.89 per hour

Experience level:

- 4 years

Schedule:

- 8 hour shift
- Day shift

Application Question(s):

- This is a W2 position, Are you ok to work on W2?

**Education**:

- Bachelor's (required)

**Experience**:

- Regulatory Regulations (FDA, Health Canada, EU MDR): 4 years (required)
- 510(k) submissions: 4 years (required)
- ISO 13485, IEC 62304, IEC 62366, ISO 14971: 4 years (required)

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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