Job #1199-02
Responsibilities will include:
* Collecting data & preparing submissions to the FDA (510k's, MDR's, IDE's &
PMA's)
* Collecting data & preparing international submissions
* Interfacing with the FDA, Notified Bodies & other international regulators
* Remaining current with FDA & international medical device regulations
* Participating in the new product development process & developing regulatory
strategies
* Coordinating Design File & Technical File development
* Participating in Quality System Audits.
Qualifications require a Bachelor's Degree or equivalent and 5 years of experience with medical device Regulatory Affairs, ISO 13485 and CE Marking.
DJO is a diversified orthopedic device company that develops, manufactures and distributes a comprehensive range of high quality orthopedic devices, including surgical implants, sports medicine equipment and products for the orthopedic rehabilitation, pain management and physical therapy industries. We offer a competitive salary and fringe benefits, including 401(k) plan. DJO is committed to a drug-free workplace and smoke-free environment.
Qualified applicants may email resumes to:
DJO Surgical at
hr@djosurgical.com
An Equal Opportunity Employer (M/F/V/D)