Details for the position are as follows :

12 month contract to start with the possibility of extension or convertion.

Location : Santa Clara, CA - 100% onsite - Open to candidates who are willing to relocate.

Rate : $52-59 an hour depending on experience level.

Job Description :

Assists in definition / implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.

Communicates issues to management through project management tracking and issue briefings. Position is highly visible to internal and external stakeholders.

Manage registrations for medical devices, ensuring compliance with regulatory requirements.

Format and organize extensive documentation, up to 200 pages, adhering to regulatory standards.

Complete technical documents for submission to government agencies in multiple countries.

Collaborate with cross-functional teams to gather necessary information for submissions.

Stay updated on regulatory requirements and changes in the medical device industry.

Ensure all documentation is accurate, complete, and submitted on time.

Required Skills :

Bachelor's degree required, masters degree preferred

Minimum of 3 years of post-graduate experience in regulatory affairs for medical devices.