Regulatory Affairs Manager - Redwood City, CA
Our client is delivering endo-imaging solutions. Established in 1919 in, they area a globally diversified company with R&D innovation and manufacturing centers in Japan, Europe and the United States. Through leading-edge optical technologies, they are providing the most advanced clinically relevant endo-imaging solutions. Together with comprehensive customer service offerings, they are collaborating with customers worldwide to create long-term partnerships and customer satisfaction.
Manager, Regulatory Affairs
The Manager, Regulatory Affairs will act as primary liaison with FDA and all international Notified Bodies. This individual will be responsible for Domestic and international Filing activities, and recall activities when necessary.
They are responsible to ensure all regulatory compliance for our client’s product line and Innovation Center location. They will also prepare reports and defense for audits.
• Act as primary liaison with FDA, a Notified Body, and International Regulatory authorities.
• Responsible for review of MDR and Vigilance reporting.
• Review and interpret regulatory rules and ensure that they are communicated through company policies and procedures.
• Organize, prepare and review FDA applications and other regulatory documents, including 510(k)s and CE MARK.
• Organize, prepare, review and maintain technical files for new or modified products.
• Budgeting and Payment of Notified Bodies for inspections and certifications
• Filing of Change Notices for impacts to the Quality System.
• Update the D0C, essential Requirements Checklist and Product Listings
• Review all product labeling and marketing materials to ensure compliance with national and international regulatory requirements.
• Organize, prepare all files for type testing CFDA filings.
• Other duties as assigned
• BS in life sciences, engineering, or equivalent required, MS preferred.
• 7+ years medical device experience.
• 5+ years in management and supervisory experience.
• Recent experience with FDA, CE MARK, CFDA filings.
• Recently held a regular full time position and is used to team work and working with others.
• Thrives on working on multiple projects and managing competing/changing priorities.
• Must understand the dynamics of a larger global company and the challenges of a small company.
• Used to working with tight timelines.
Redwood City, CA
United States of America
Clinical/Scientific / Healthcare - Clinical
Temp to Hire Position
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Job Title: Regulatory Affairs Manager
Location: Redwood City, CA
Job Type: Temp to Hire Position
Reference ID: 338001
Posted Date: 9/4/2018