Maintains and advance’s the organization's ongoing relationships with regulatory commissions and authorities. Coordinates and conducts the assessment of internal controls to ensure Pre Market and On Market product compliance as required by regulatory commissions and authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints. Prepares and sponsors testimony to governmental or regulatory agencies. Regulatory operations activities including trade compliance (listings, document preparation, legalization) and ongoing establishment license maintenance. Ensure advertising and promotional items are compliant to regulatory requirements. Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information. Engages with industry associations to shape future regulations.

　　Accountability

　　Operating within practices and procedures covered by precedents or well-defined policies and review of end results. Decision making authority also allows modification of practices and procedures, determine own priorities. Non-Financial impact. Role is an advisory & diagnostics type of role.

　　Problem Solving

　　Thinking environment is somehow constrained by policies / procedures. Generally able to resolve problems using past experience or precedents. Complexity comes in terms of changes in regulatory changes in global or local quality & regulatory standards and requirements.

　　Know How

　　Bachelor’s degree with 3 years of experience in RA, product registration, medical diagnostics. Individual contributor role. Primary contact for regulatory governance within the affiliate.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]