Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. **The Opportunity** As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions. This is a broad scoped position with strong opportunity for growth and career development based on performance. **What You’ll Work On** + Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input. + Assist with promotional content development and review for compliance before distribution. + Assist in Regulatory Affairs Ad & Promo SOP development and review. + Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed + Determine and communicate promotional content and approval requirements to cross functional teams. + Assist compliance with product post-marketing approval requirements as needed. **Core Responsibilities** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. + Creates, reviews and approves engineering changes. + Reviews and provides input on device labeling. + Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. + Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel. + May interface directly with FDA and other regulatory agencies. + Supports the product release process by creating GTS licenses or reviewing and approving requests for product release. + Reviews protocols and reports to support regulatory submissions. + Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. + Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. **Required Qualifications** + Bachelors Degree (± 16 years), Technical discipline preferred + Minimum 3 years, Related experience, including a minimum of two years regulatory experience + Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. + Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. + Ability to travel approximately 5%, including internationally. **Preferred Qualifications** + Medical Device industry experience. + Experience working in a broader enterprise/cross-division business unit model. + Strong problem-solving skills and ability to think strategically and see the big picture. + Adaptable with the ability to switch priorities and accomplish all tasks. + Process oriented. + Preferred 510k experience + Preferred Class II or Class III device experience The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted. 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 corpjat@abbott.com