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.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, nutritional's and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Working at AbbottAt 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 of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn 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 bachelor’s 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.Cardiac Rythm Management Business Mission: why we existOur business purpose is to restore health and improve quality of life through the design and provision of device and Cardiac Rythm Management solutionsThe Opportunity –We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in Sylmar CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.What You’ll Work On -Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:Strategic Planning:Develop new regulatory policies, processes and SOPs and train key personnel on themEvaluate regulatory risks of division policies, processes, proceduresProvide regulatory input to product lifecycle planningMonitor regulatory outcomes of initial product concepts and provide input to senior regulatory managementAssist in the development of multicountry regulatory strategy and update strategy based upon regulatory changesAssist in regulatory due diligence for potential and new acquisitionsUtilize technical regulatory skills to propose strategies on complex issuesDetermine submission and approval requirementsIdentify emerging issuesMonitor trade association positions for impact on company productsAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teamsDevelop and mentor regulatory professionalsPremarket:Assess the acceptability of quality, preclinical and clinical documentation for submission filingCompile, prepare, review and submit regulatory submission to authoritiesMonitor impact of changing regulations on submission strategies and update internal stakeholdersMonitor applications under regulatory reviewCommunicate application progress to internal stakeholdersMonitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authoritiesEvaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategiesNegotiate and interact with regulatory authorities during the development and review process to ensure submission approvalProvide strategic input and technical guidance on regulatory requirements to development teamsManage and execute preapproval compliance activitiesPostmarket:Oversee processes involved with maintaining annual licenses, registrations, listings and patent informationEnsure compliance with product postmarketing approval requirementsReview and approve advertising and promotional items to ensure regulatory complianceEnsure external communications meet regulationsDevelop, implement and manage appropriate SOPs and systems to track and manage product-associated eventsJob specific responsibilities may include (choose applicable areas and expand as appropriate);Medical writingAdvertising and promotionLabelingRestricted substances reporting as required (e.g. REACH)Compendial / standardsImport / exportCountry specific regulatory supportIndividuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.Influence/Leadership:Develops, communicates, and builds consensus for operating goals that are in alignment with the division.Provides leadership by communicating and providing guidance towards achieving department objectives.Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.May lead a cross-functional or cross-divisional project team.Provides technical leadership to business units.Acts as a mentor to less-experienced staff.Exercises judgment independently.Planning/Organization:Creates immediate to long-range plans to carry out objectives established by top management.Forecasts project related needs including human and material resources and capital expenditures.Decision Making/Impact:Assignments are expressed in the form of objectivesMakes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.Required Qualifications –Bachelors Degree (± 16 years) , Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)Minimum 4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory 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.Background / Skills / Knowledge Regulatory Knowledge of (as applicable):Regulatory history, guidelines, policies, standards, practices, requirements and precedentsRegulatory agency structure, processes and key personnelPrinciples and requirements of applicable product lawsSubmission/registration types and requirementsGxPs (GCPs, GLPs, GMPs)Principles and requirements of promotion, advertising and labelingInternational treaties and regional, national, local and territorial trade requirements, agreements and considerationsDomestic and international regulatory guidelines, policies and regulationsEthical guidelines of the regulatory profession, clinical research and regulatory processCommunication Skills or Ability to:Communicate effectively verbally and in writingCommunicate with diverse audiences and personnelWrite and edit technical documentsWork with cross-functional teamsWork with people from various disciplines and culturesWrite and edit technical documentsNegotiate internally and externally with regulatory agenciesPlan and conduct meetingsCognitive Skills or Ability to:Pay strong attention to detailManage projectsCreate project plans and timelinesJuggle multiple and competing prioritiesThink analytically with good problem solving skillsOrganize and track complex informationExercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining resultsHas broad knowledge of various technical alternatives and their potential impact on the businessExercise good and ethical judgment within policy and regulationsUse in-depth knowledge of business functions and cross group dependencies/ relationshipsDefine regulatory strategyFollow scientific arguments, identify regulatory scientific data needs and solve regulatory issuesPerform risk assessment or analysisLead functional groups in the development of relevant data to complete a regulatory submissionPreferred Qualifications –Experience working with Windchill or similar Product Lifecycle Management (PLM) softwareExperience writing procedures and SOPsExperience working with 510k and PMA submissionsThe base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
