Senior Regulatory Affairs Specialist

Company: Abbott Laboratories
Location: Buffalo Grove
Posted on: January 10, 2022

Job Description:

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 109,000 colleagues serve people in more than 160 countries.At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. ***Position is based at our manufacturing facility in Buffalo Grove, IL.*** This new Senior RA Specialist position at ADC will focus on manufacturing capacity expansion projects for our FreeStyle Libre product family from a regulatory affairs perspective. Experience with reviewing manufacturing validation documentations and change management experience is crucial.Position SummaryAs 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.-- - This position may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.-- - This individual may assist in identifying and obtaining data needed, and ensuring that its effectively presented for the registration of products worldwide.-- - The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. This individual will be the key Regulatory Affairs contact for the manufacturing facility in Buffalo Grove, IL. This is a broad scoped position with strong opportunity for growth and career development. Main ResponsibilitiesMay prepare or oversee such preparation documentation needed for product registration worldwide.Assist in SOP development and review-- -Provide regulatory input to product lifecycle planningContinue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.Assist in the development of regional regulatory strategyUnderstand, 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 obstaclesDetermine and communicate submission and approval requirementsParticipate in risk benefit analysis for regulatory complianceAssess the acceptability of quality, preclinical and clinical documentation for submission filingCompile, prepare, review and submit regulatory submission to authoritiesMonitor impact of changing regulations on submission strategies.Monitor applications under regulatory reviewEvaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategiesNegotiate and interact with regulatory authorities during the development and review process to ensure submission approval.Assist compliance with product post marketing approval requirements.Review 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.Provide regulatory input for product recalls and recall communications. EDUCATION AND EXPERIENCE YOU'LL BRING Required -At least three (3) years of regulatory affairs experience FDA/EU or international regulatory experience is required. Bachelors degree (or equivalent combination of Education and Work Experience) is required. Preferred - Experienced in medical devices with class II or III PMA products preferred.Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.-- - Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:A fast-paced work environment where your contribution is essential to successTraining and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully:-- - -- -Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.-- -Connect with us at , on Facebook at /Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, Buffalo Grove , Senior Regulatory Affairs Specialist, Other , Buffalo Grove, Illinois