{"id":1160278,"url":"https://alion.io/job/abbott-laboratories-regulatory-affairs-specialist-vascular-on-site","title":"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":"junior","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":81500,"max":141300,"currency":"USD","period":"year","gross":null,"usd_annual":141300},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-23T23:25:26Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-24T16:46:44Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"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 passionate, experienced Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will support EU and US regulatory activities and collaborate with the global regulatory organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas to ensure regulatory considerations are integrated throughout the product lifecycle. Proven successful track record of preparing submissions and documentation in compliance with relevant medical device regulations is preferred.\nWhat You’ll Work On\nEvaluate regulatory impact and develop global regulatory strategies to support product lifecycle management activities.\nPrepare and support regulatory submissions for Vascular devices to achieve departmental and organizational objectives.\nAssess proposed product, manufacturing, supplier, process, and labeling changes to determine regulatory impact and submission requirements across global markets.\nDevelop and document regulatory assessments supporting design control and change management activities.\nReview and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.\nActs as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.\nSupport maintenance of regulatory approvals and registrations for commercially marketed products.\nSupport the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers.\nSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.\nComplies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. \nMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.\nPerforms other related duties and responsibilities as assigned.\nRequired Qualifications\nBachelor’s degree (or equivalent)\n2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. \nAbility to work within a team environment and accomplish projects within a fast-paced, matrixed environment.\nStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization.\nPreferred Qualifications\nBachelor’s degree in science (biology, chemistry, microbiology, etc.), engineering, or biomedical fields. \nMaster’s degree in Regulatory Affairs.\nCertification is a plus (such as RAC from the Regulatory Affairs Professionals Society).\nExperience within the medical device industry, particularly supporting Class II and/or Class III products.\nExperience supporting commercially marketed medical devices, including post-market compliance and regulatory maintenance activities.\nExperience authoring or supporting regulatory submissions and regulatory strategies that resulted in successful regulatory outcomes.\nExperience with U.S. regulatory submissions, including Traditional, Special, and Abbreviated 510(k)s, PMAs, and PMA supplements.\nExperience with EU MDR (2017/745) Technical Documentation and change assessments.\nWorking knowledge of medical device regulations and international standards, including ISO 13485, and ISO 14971.\nExperience conducting regulatory assessments associated with design, manufacturing, supplier, labeling, and process changes.\nExperience with risk management activities and documentation in accordance with ISO 14971.\nExperience working within medical device quality systems and design control environments.\nExperience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, and change control processes.\nAbility to work effectively in a highly matrixed and geographically diverse organization.\nExperience with cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies is preferred. \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.\nThe base pay for this position is\n$81,500.00 - $141,300.00In specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nRegulatory OperationsDIVISION:\nAVD VascularLOCATION:\nUnited States > Santa Clara : Building B - SCADDITIONAL LOCATIONS:\nUnited States > Temecula : Building E - TEWORK SHIFT:\nStandardTRAVEL:\nYes, 5 % 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":7960,"description_truncated":false,"requirements":{"experience_years_min":2,"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"],"lifecycle":[{"event":"open","at":"2026-09-23T23:25:26Z"}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":15,"reasons":["conf:2","velocity","win:early","comp:junior,brand"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":141300,"is_top_pay":true},"html_url":"https://alion.io/job/abbott-laboratories-regulatory-affairs-specialist-vascular-on-site","json_url":"https://alion.io/job/abbott-laboratories-regulatory-affairs-specialist-vascular-on-site.json","meta":{"generated_at":"2026-09-24T17:51:08Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}