Major, On-Going Responsibilities: • Oversees all programs, policies and practices to ensure business units effectively and accurately address, analyze and resolve issues and are in global regulatory compliance; • Responsible for effective management of all applicable global adverse event reporting to meet regulatory requirements and company goals including; • Complaint investigations • CAPA • Field Reports • MDRs/MDV • Assessments for recall • Field Reports • Manages continuous improvement of the global complaint management process using best practice(s), world class, and PE approaches to ensure continuous compliance with FDA and other applicable regulations and ISO standards. • Reduce regulatory exposure through increased efficacy in management of product complaints and investigations by improvement in multiple complaint process metrics. • Ensure complaint systems and processes provide measurable impact to quality, cost and customer value. • Responsible for establishing and maintaining policies and procedures to ensure compliance with international, state and federal regulations and standards including compliance with all FDA and MDD regulations governing adverse event reports such as MDR, MDV and all other applicable global reporting requirements. • Maintains up-to-date knowledge of FDA and EU regulations and applicable worldwide standards and requirements • Manages all customer interface points and ensures timely and effective communications with customers regarding complaints and complaint investigations; ensures customer satisfaction by optimizing customer communication from initial call to final follow-up. • Responsible for preparation, onsite management and follow-up for compliance standards and corporate audits relating to the global complaint process and guidelines as well as managing and participating in pre-assessment and post-certification audit activities. • Develop and maintain strong relationships with all stakeholders • Assure post-market product experience is fed back into sustaining engineering as well as new product development

Other Skills/Characteristics: • Gets Results – creates an environment of accountability for meeting agreed upon expectations • Communicates Effectively – adjusts the message to the audience to get the point across • Gets Work Done Through Others – manages people well, gets the most/best out of people • Decisive & Good Judgment – decisions are based on data and sound reasoning • Influencing – champion initiatives that generate organization-wide understanding and support • Problem Solving – establish resources, processes to gather information/data for problem solving or analysis.

Qualified candidates should apply online via our website at http://www.sjm.com/careers and reference position NMD2346. No agencies or phone calls, please.