Principal Regulatory Affairs Specialist – Vascular (on-site)

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. 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 Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The Opportunity We are seeking a Principal Regulatory Affairs Specialist to join Abbotts Vascular Division on-site in Santa Clara, CA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies. What Youll Work On Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements Develops global regulatory strategies for new and modified products Prepares and submits PMA/ HDE/ IDE Submissions and Supplements. Works with international affiliates to compile and submit international product registrations and licensing applications Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements Supports the product release process by creating GTS licenses or reviewing and approving requests for product release Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes Reviews protocols and reports to support regulatory submissions Creates, reviews and approves engineering change requests Acts as liaison between the company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors 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 M.S. or Ph.D. in a technical area 5-7 years experience in a regulated industry with experience working with Class III devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) Previous experience with PMA / IDE and international submissions Experience with combination products and/or Class III medical devices Ability to work effectively on project teams Must be able to manage multiple and competing priorities and manage programs with minimal oversight. Has a strong attention-to-detail Strong written, verbal, presentation, and organizational skills Strong analytical and problem-solving skills Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies Ability to identify risk areas and escalate issues as appropriate 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 $100,000.00 $200,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: AVD Vascular LOCATION: United States > Santa Clara : Building B - SC ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) 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