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Regulatory Affairs Project Manager

2 months ago

Santa Clara, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

Job Title: Regulatory Affairs Project Manager

Location: Santa Clara, CA-95054 (100% Onsite)

Duration: 12 months contract

Shift: 8am-5pm

Job Roles & Responsibilities:

Support IVDR compliance activities including creation of technical files, post market surveillance activities

New product development documentation

On market support:

Regulatory impact assessments, etc.

Regulatory operations:

BUDI number updates, label reviews, FDA laser report, state manufacturing license etc.

Product Develop

Regulatory Support

Impact Regulatory Support

Supporting Application for state license in US

5 years' experience

Organized Skillset

Be aware of regulations, Medical Device

IVDR for US and Europe

Exp working in an ISO Certified environment. ISO 13485

Experience working in regulatory environment

Preferred

5 years Exp. Invitro Diagnostic Medical Devices