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Regulatory Affairs Specialist II: DJO

Position Description:

We are currently seeking a Regulatory Affairs Specialist II at our global headquarters in Vista, CA.

This position is responsible for support activities related to Domestic Food and Drug Administration (FDA) and International device and plant listings, registrations, and import/export processes. The incumbent will participate in the maintenance of the technical file, and device master record for compliance to US, Canada, European Union, Japan and other global markets. The incumbent is also responsible for supporting all programs and projects related to USFDA and global regulatory compliance including adverse event and remedial action reporting. This position reports directly to the VP, Global Regulatory Affairs

Essential Duties and Responsibilities:
Include the following. Other duties may be assigned.
• Provide Regulatory Affairs support to assure compliance to market requirements and company policies and procedures.
• Provide regulatory support in the compilation of pre- and post market product applications and sustaining product support to assure requirements are met in accordance with FDA, ISO, CMDR and the MDD.
• Support in the development and review of protocols to support validation studies for new and existing product to assure that all aspects are addressed in compliance with domestic and international requirements.
• Reviews changes to existing devices and processes for compliance to QSR, ISO standard change control requirements.
• Responsible for the generation of MDR's and reports related to the MDR as directed.
• Assists the RA Manager in the support of due-diligence review of future acquisitions and will support the transfer of products into the USA and other DJO facilities.
• Provides support in the review of the company Quality Records System to assure it complies with all FDA, MDD, and CMDR requirements and ISO certification.
• Participates in the preparation and review of engineering specifications and quality programs in response to adverse quality levels or return trends.
• May be required to travel to other manufacturing operations.


Headquartered in San Diego, CA (Vista), DJO Incorporated is a leading global provider of high-quality, orthopedic devices, with a broad range of products used for rehabilitation, regeneration, pain management and physical therapy sold through our DonJoy, Empi, CMF, Aircast / Procare, and Chattanooga Group business units.

We are the largest non-surgical orthopedic rehabilitation device company in the United States and among the largest globally. We also develop, manufacture and distribute a broad range of surgical reconstructive implant products through our DJO Surgical business unit.

We believe that our strong brand names, comprehensive range of products, focus on quality, innovation, customer service, extensive distribution network, and our strong relationships with orthopedic and physical therapy professionals have contributed to our leading market positions.



Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:
• Associates Degree at minimum, a 4 year degree in a field of science is preferred.
• Two to five years or equivalent combination of education and experience in a regulatory affairs support position or combination of both.


DJO is a portfolio company of the Blackstone Group.
EEO/AA-M/F/VET/HANDICAP

Apply Only at : DJO Incorporated