Major, On-Going Responsibilities: • Establish clear policies and procedures for complaint handling for all locations within the Neuromodulation Division that are compliant with current regulations. • Responsible for timely complaint closures and linkages of investigations to individual complaint records • Ensure complaint and MDR reporting requirements are understood and met • Support the reporting and follow-up of product recalls, if any • Remain current on related regulations and guidelines published by FDA and international regulatory authorities • Research various actions taken by FDA and other regulatory bodies to gain insight into current enforcement practices and the Agency’s rationale for such actions • Provide interpretations and direction to appropriate personnel regarding the regulatory requirements relevant to the Product Complaint and Field Support organizations • Initiate changes to practices and procedures to ensure compliance with internal and external requirements • Design and provide training on topics related to the compliance of the product complaint SOP’s for all applicable employees • Bring regulatory compliance questions/issues to the attention of senior management • Participate in internal compliance inspections/audits, as well as support other units during inspections as requested

Qualified candidates should apply online via our website at http://www.sjm.com/careers and reference position NMD2345. No agencies or phone calls, please.