Principal Regulatory Affairs Specialist (Business Partnerships).

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. Youll 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 bachelors 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. At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thats why were 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. Were revolutionizing the way people monitor their glucose levels with our new sensing technology. The Opportunity The Principal RA Specialist Business Partnerships will work on-site out of our Alameda, CA location in the Diabetes Care Division. Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilitiesrelated to new strategic business initiatives globally , which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs. Projects will focus on driving the regulatory strategy for business partnership initiatives involving Cloud/ Sensor based external partnerships .. The individual has department level influence with experience in global regulatory submissions and on-market changes, and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory compliance strategy, and provide executive management with regulatory metrics/information. What Youll Work On · Develop global regulatory strategies for product development and planning throughout the product lifecycle. · Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. · Provide technical leadership and strategic input on complex issues and to business units. · Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. · Create project plans and timelines. · Support functional groups in the development of relevant data to complete a regulatory submission. · Write and edit technical documents. · Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions. · Review and approve labeling to ensure compliance. · Monitor emerging issues and identify solutions. · Negotiate internally and externally as regulatory liaison · Evaluate regulatory risks of corporate policies. · Oversee processes & improvements involved with Partnership regulatory activities · Ensure compliance with product post-marketing approval requirements. · Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. · Actively contribute to the development and functioning of the crisis/issue management program · Analyze product-associated problems and develop proposals for solutions. · Provide regulatory input for product recalls and recall communications. Required Qualifications · Bachelors Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications) · Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices. · Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Preferred Qualifications · 5 years experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. · Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international medical device regulations and submissions. · Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines. · Experience with word processing, spreadsheet and presentation graphic software packages. · Experience working in a broader enterprise/cross-division business unit model. · 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. · Ability to identify, solve problems, and work independently with little oversight. · Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. · Multitasks, prioritizes, and meets deadlines in a timely manner. · Strong organizational and follow-up skills, as well as attention to detail. · Ability to travel approximately 5%, including international travel. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $86,700.00 $173,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: ADC Diabetes Care LOCATION: United States > Buffalo Grove : 1250 Barclay Blvd ADDITIONAL LOCATIONS: United States > Alameda : 2601 Harbor Bay Parkway WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter