Senior Regulatory Affairs Specialist

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 115,000 colleagues serve people in more than 160 countries.       JOB DESCRIPTION: 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, the function of a Senior Regulatory Affairs Specialist is to provide support for the   regulatory department to ensure efficient and compliant business processes and environment.   The individual   may execute tasks and play a consultative role by partnering across business functions. The individual may   assist   in   identifying   data needed, obtaining these   data   and ensuring that they are effectively presented for the   registration   of products worldwide. The individual may prepare and   submit   documentation needed for registration   worldwide or may oversee such preparation.   MAIN RESPONSIBILITIES   • Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle   planning . Continue to revisit and compare regulatory outcomes with   initia l   product concepts to make   recommendations on future actions.   Assis t   in the development of regional regulatory strategy and update   strategy based upon regulatory changes.   • Understand,   investigate   and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic   context   in order to   assess regulatory implications for approval.   Determine   trade issues to   anticipate   regulatory   obstacles.   Determine   and communicate submission and approval requirements. Participate in risk-benefit   analysis   for regulatory compliance.   • Premarket: Assess the acceptability of quality,   preclinical   and clinical documentation for submission filing.   Compile, prepare,   review   and   submit   regulatory   submission   to authorities.   •   Monitor   impact of changing regulations on submission strategies. Monitor applications under regulatory review.   Monitor and submit applicable reports to regulatory authorities.   Evaluate proposed preclinical,   clinical   and manufacturing changes for regulatory filing strategies.   Negotiate and interact with regulatory authorities during   the   development and review process to ensure submission approval   is important.   • Post market:   Maintain   annual licenses, registrations,   listings   and patent information.   Assist   compliance with   product   post marketing approval requirements.   • Review and approve advertising and promotional items to ensure regulatory compliance. Assess external communications   relative   to regulations. Review of regulatory aspects of contracts.   Assist   with label development and review for compliance before release. •   Submit   and review change controls to   determine   the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions. • Contribute to the development and functioning of the crisis / issue   management program. Ensure product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications   Job   specific responsibilities may include (choose applicable areas and expand as   appropriate) . Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration. Manage   rest   of   world   (all geographies outside the US and EU) submissions.   •Serve   as a regulatory team member on product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system products. • Assist   company   SME’s   to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects,   testing   and record keeping.   May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory.   •Proactively track global regulatory requirement changes and work with   Global   Strategic Intelligence (GSI) team to   disseminate