Job Location : Sylmar,CA, USA
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'sand 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.You'llalso 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) PPO
An excellent retirement savings plan with high employer contribution· Tuition reimbursement, the Freedom 2 Save student debt program andFreeUeducation benefit - An affordable and convenient path to getting a bachelor's degree.
A company recognized asa great placeto 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 ManagementBusiness Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device andCardiac Rythm Management solutions
The Opportunity–
WeareseekingaRegulatoryAffairs Project ManagertojoinourCardiacRythmManagementteaminSylmarCA. Asanindividualcontributor,thefunctionofaRegulatoryAffairs Project Manageristocombineknowledgeofscientific,regulatoryandbusinessissuestoenableproductsthataredeveloped,manufacturedordistributedtomeetrequiredlegislation. Theindividualhasdepartment/group/sitelevelinfluenceandisgenerallyrecognizedasanexpertresourcewithinthedepartment. Theindividualmayshareknowledgeandexpertisewithothersinsupportofteamactivities. Theindividualmayidentifydataneeded,obtainthesedataandensurethattheyareeffectivelypresentedfortheregistrationofproductsworldwide.
WhatYou'llWork 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 them
Evaluate regulatory risks of division policies, processes, procedures
Provide regulatory input to product lifecycle planning
Monitor regulatory outcomes ofinitialproduct concepts and provide input to senior regulatory management
Assist in the development ofmulticountryregulatory strategy and update strategy based upon regulatory changes
Assistin regulatory due diligence for potential and new acquisitions
Utilize technical regulatory skills to propose strategies on complex issues
Determinesubmission and approval requirements
Identify emerging issues
Monitor trade association positions for impact on company products
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Develop and mentor regulatory professionals
Premarket:
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare,reviewandsubmitregulatory submission to authorities
Monitor impact of changing regulations on submission strategies and update internal stakeholders
Monitor applications under regulatory review
Communicate application progress to internal stakeholders
Monitor andsubmitapplicable reports and ensureappropriate responsesaresubmittedto regulatory authorities
Evaluate proposed preclinical,clinicaland manufacturing changes for regulatory filing strategies
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Provide strategic input and technical guidance on regulatory requirements to development teams
Manage and execute preapproval compliance activities
Postmarket:
Oversee processes involved withmaintainingannual licenses, registrations,listingsand patent information
Ensure compliance with productpostmarketingapproval requirements
Review and approve advertising and promotional items to ensure regulatory compliance
Ensure external communications meet regulations
Develop,implementand manageappropriate SOPsand systems to track and manage product-associated events
Job specific responsibilities may include(choose applicable areas and expand asappropriate);
Medical writing
Advertising and promotion
Labeling
Restricted substancesreporting asrequired(e.g.REACH)
Compendial / standards
Import / export
Country specific regulatory support
Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues,and mustassurethat 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 indeterminingtechnicalobjectivesof assignments. Completed work is reviewed from arelatively long- term perspective for desired results.Individual isrecognized asa discipline expertandresourcein regulatoryaffairs.
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 departmentobjectives.
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 outobjectivesestablishedby top management.
Forecasts project related needs including human and material resources and capital expenditures.
Decision Making/Impact:
Assignments are expressed in the form of objectives
Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
Consequences oferroneousdecisions 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–
BachelorsDegree (± 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 lawishelpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Minimum 4years experiencein 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,requirementsand precedents
Regulatory agency structure,processesand key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
GxPs(GCPs, GLPs, GMPs)
Principles and requirements of promotion,advertisingand labeling
International treaties and regional, national,localand territorial trade requirements,agreementsand considerations
Domestic and international regulatory guidelines,policiesand regulations
Ethical guidelines of the regulatory profession, clinicalresearchand regulatory process
Communication Skills or Ability to:
Communicate effectively verbally and in writing
Communicate with diverse audiences and personnel
Write and edit technical documents
Work with cross-functional teams
Work with people from various disciplines and cultures
Write and edit technical documents
Negotiate internally and externally with regulatory agencies
Plan and conduct meetings
Cognitive Skills or Ability to:
Pay strong attention to detail
Manage projects
Create project plans and timelines
Juggle multiple and competing priorities
Think analytically with goodproblem solvingskills
Organize and track complex information
Exercise judgment within broadly defined practices and policies in selecting methods,techniquesand evaluation criteria for obtaining results
Has broad knowledge of various technical alternatives and their potential impact on the business
Exercise good and ethical judgment within policy and regulations
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Define regulatory strategy
Follow scientific arguments,identifyregulatory scientific dataneedsand solve regulatory issues
Perform risk assessment or analysis
Lead functional groups in the development of relevant data to complete a regulatory submission
Preferred Qualifications–
Experience working with Windchill or similar Product Lifecycle Management (PLM) software
Experience writing procedures and SOPs
Experience working with 510k and PMA submissions
The base pay for this position is $112,000.00– $224,000.00. In specific locations, the pay range may vary from the range posted.