Regulatory Affairs Specialist(W2 Only) - Palo Alto, United States - Infosoft Teksolutions

Infosoft Teksolutions

Verified Company

Palo Alto, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 countryspecific requirements necessary for
productrelated 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 countryspecific requirements.

Experience:

58 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 as evidenced by coursework or submissions that required the use of each standard
Teamwork and collaboration:
Proficient in utilizing business tools such as Email, Microsoft Word, Excel, PowerPoint, and Adobe Pro.