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 ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar yearAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA 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 FortuneA 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 Abbott’s 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 You’ll 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 requirementsDevelops global regulatory strategies for new and modified productsPrepares and submits PMA/ HDE/ IDE Submissions and Supplements. Works with international affiliates to compile and submit international product registrations and licensing applicationsInterprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system proceduresReviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulationsMaintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirementsSupports the product release process by creating GTS licenses or reviewing and approving requests for product releaseActs as an SME for internal and external audits and inspections by internal teams or external regulatory authoritiesComplies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processesReviews protocols and reports to support regulatory submissionsCreates, reviews and approves engineering change requestsActs as liaison between the company and the various regulatory agencies. Interfaces directly with FDA and Notified BodiesMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Required Qualifications

Bachelor’s 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 devicesExperience 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 area5-7 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 submissionsExperience with combination products and/or Class III medical devicesAbility to work effectively on project teamsMust be able to manage multiple and competing priorities and manage programs with minimal oversight.Has a strong attention-to-detailStrong written, verbal, presentation, and organizational skillsStrong analytical and problem-solving skillsWorking knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographiesAbility 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.