Device RA Manager

Primary purpose and function of this position:

Provide Regulatory Guidance for device and drug/device combination elements throughout full product life cycle .

Review device life-cycle documentation

Support compliance assurance to local authorities and regulations.

Lead device labeling activities

Lead post marketing changes

Lead Regulatory projects and provide specific strategy to post market changes

Regulatory point of contact for some device vendors

Lead device specific submission chapters

Education & Experience

· BS in engineering or equivalent.

· 8+ years RA experience in supporting a medical device development and manufacturing environment.

Knowledge, Skills & Abilities: 

· Post market experience

· Working knowledge of QSR’s, ISO 13485, MDD/MDR, MDSAP, and FDA requirements and standards.

· SW RA knowledge - advantage

· Strong interpersonal, communication, analytical and complex problem solving skills.

· Ability to take ad-hoc decisions and communicate properly to management

· The ability to develop partnerships and influence.

· Ability to work independently.

· An understanding of the principles of configuration management and document control.