{"id":982974,"url":"https://alion.io/job/abbott-laboratories-principal-regulatory-affairs-specialist-vascular-on-site-3","title":"Principal Regulatory Affairs Specialist – Vascular (on-site)","company":{"id":2710,"name":"Abbott Laboratories","domain":"abbott.com","url":"https://alion.io/company/abbott","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":100,"open_postings":88,"ghost_share":0,"stale_share":0,"repost_share":0.023,"time_to_fill_p50_days":15,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Santa Clara, United States","United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":86700,"max":173300,"currency":"USD","period":"year","gross":null,"usd_annual":173300},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-16T22:16:35Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-09-24T16:46:44Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"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 122,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:\nWorking at Abbott\nAt 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:\nCareer development with an international company where you can grow the career you dream of\nEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.\nAn excellent retirement savings plan with high employer contribution\nTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree\nA 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\nA 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\nAbbott 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.\nThe Opportunity\nAbbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making by interpreting regulatory requirements, evaluating business risks, and developing practical regulatory solutions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.\nWhat You’ll Work On\nDevelop and execute global regulatory strategies to support product changes, manufacturing transfers, lifecycle management activities, new product development, and business objectives.\nIndependently prepare regulatory submissions and documentation for medical devices.\nLead regulatory assessments for design, manufacturing, supplier, labeling, and process changes to determine global regulatory requirements and submission strategies.\nReview and approve engineering change orders, protocols, reports, specifications, risk management documentation, validation documents, and other project-related records.\nSupport and maintain U.S. and international product registrations, licenses, approvals, and technical documentation throughout the product lifecycle.\nServe as the regulatory lead on cross-functional project teams, providing strategic guidance throughout product development and commercialization activities.\nInterpret and apply global regulatory requirements, standards, guidance documents, and industry best practices to support business needs.\nPrepare and maintain FDA submissions, including 510(k)s, PMAs, PMA supplements, and other required submissions, as applicable.\nSupport EU MDR regulatory activities, including Technical Documentation updates, change assessments, and notified body interactions.\nCollaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain, Marketing, and other functional groups to ensure timely execution of regulatory deliverables.\nAnalyze evolving regulatory requirements and provide recommendations regarding business impact, compliance risks, and implementation plans.\nSupport regulatory authority and notified body inspections, audits, inquiries, and responses.\nSupport all company initiatives in accordance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and applicable regulatory requirements.\nMaintain compliance with FDA regulations, international regulations, company policies, procedures, and quality requirements.\nMaintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.\nAct as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.\nMay manage direct reports or serve as mentor to other regulatory affairs specialists\nPerform other duties and responsibilities as assigned.\nRequired Qualifications\nBachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)\nExperienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.\nExperience 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).\nPreferred Qualifications\n6-8 years experience in medical device industry with experience working with Class II and/or Class III devices.\nRegulatory affairs professional experience supporting medical devices.\nExperience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies.\nCertification is a plus (such as RAC from the Regulatory Affairs Professionals Society).\nMust be able to manage multiple and competing priorities and manage programs with minimal oversight.\nHas a strong attention-to-detail\nStrong written, verbal, presentation, and organizational skills as well as analytical and problem-solving skills.\nWorking knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.\nExperience authoring and submitting Traditional, Special, or Abbreviated 510(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions.\nExperience supporting EU MDR (2017/745) Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions.\nKnowledge of global regulatory requirements and submission pathways outside the United States and European Union; in particular highly regulated countries such as China, Canada, Australia, or Brazil.\nExperience participating in regulatory authority inspections, notified body audits, and responses to regulatory inquiries.\nExperience reviewing risk-based regulatory assessments and supporting product risk management activities in accordance with ISO 14971.\nExperience reviewing clinical data.\nExperience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, eQMS platforms, and change control processes.\nAbility to work in a highly matrixed and geographically diverse business environment.\nAbility to work effectively within a team and as an individual contributor in a fast-paced, changing environment.\nExperience managing direct reports or dotted line manager to regulatory affairs specialists\nAbility to leverage, manage and/or engage others to accomplish projects.\nApplies critical thinking to multitask, prioritize and meet deadlines in a timely manner.\nAbility to identify risk areas and escalate issues as appropriate.\nApply Now\nLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives:www.abbottbenefits.com\nFollow 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.\nConnect 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.\nThe base pay for this position is\n$86,700.00 - $173,300.00In specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nRegulatory OperationsDIVISION:\nAVD VascularLOCATION:\nUnited States > Temecula : Building B - TBADDITIONAL LOCATIONS:\nUnited States > Santa Clara : Building B - SCWORK SHIFT:\nStandardTRAVEL:\nYes, 10 % of the TimeMEDICAL SURVEILLANCE:\nNoSIGNIFICANT WORK ACTIVITIES:\nAwkward/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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf","description_format":"text","description_chars":9425,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Devices","Diagnostics","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-09-16T22:16:35Z"}],"liveness":{"score":70,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.78,"p_room":0.9,"age_days":7,"expected_fill_days":15,"reasons":["conf:2","velocity","win:mid","comp:brand"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":173300,"is_top_pay":false},"html_url":"https://alion.io/job/abbott-laboratories-principal-regulatory-affairs-specialist-vascular-on-site-3","json_url":"https://alion.io/job/abbott-laboratories-principal-regulatory-affairs-specialist-vascular-on-site-3.json","meta":{"generated_at":"2026-09-24T18:36:47Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}