Description
Job Description:* Take a lead role in authoring 510(K) clearances for current products as well as products in the company's pipeline
* Determine global regulatory pathways for various products including product classification and type of regulatory submission or rationale required
* Participate on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales
* Identify guidance documents, international standards and Consensus Standards and assists teams with their interpretation
* Assist with FDA facility inspections and other types of audits and inspections as needed
Requirements and qualifications:
* 2 + years experience in regulatory affairs in medical devices
* Significant experience with 510(K) clearances
* Bachelor's degree, preferable in a technical or scientific discipline
* Strong communications and analytical skills: oral, written and electronic
* Ability to succeed in a highly regulated compliance oriented environment while still providing service excellence
* Positive attitude, ability to work autonomously
Benefits:
The company offers a wide range of benefits, including, comprehensive medical and dental insurance at competitive rates, life insurance, short and long term disability insurances which are company paid, 401(k) plan with a company match, defined contribution retirement plan, generous paid time off policy for work life balance, and the opportunity to work on the latest technology and with the most dedicated people.
To find out more about Real please visit www.realstaffing.com