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
• Experience with FDA 510(k) applications, Health Canada license applications, and EU MDR technical files

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:
• Experience with FDA 510(k) applications, Health Canada license applications, and EU MDR technical files
• 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