Abbott
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 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 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 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 exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and Cardiac Rythm Management solutions The Opportunity We areseeking a Regulatory Affairs Project Manager tojoinourCardiacRythm Management teaminSylmar CA. As anindividualcontributor, thefunctionof a Regulatory Affairs Project Manager istocombineknowledgeofscientific, regulatoryandbusinessissuestoenableproductsthataredeveloped, manufacturedordistributedtomeetrequiredlegislation. The individualhasdepartment/group/sitelevelinfluenceandisgenerallyrecognizedasanexpertresourcewithinthedepartment. The individualmayshareknowledgeandexpertisewithothersinsupportofteamactivities. The individualmayidentifydataneeded, obtainthesedataandensurethattheyareeffectivelypresentedfortheregistrationofproductsworldwide. 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 them
Evaluate regulatory risks of division policies, processes, procedures
Provide regulatory input to product lifecycle planning
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes
Assist in regulatory due diligence for potential and new acquisitions
Utilize technical regulatory skills to propose strategies on complex issues
Determine submission 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, review and submit regulatory 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 and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
Evaluate proposed preclinical, clinical and 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 with maintaining annual licenses, registrations, listings and patent information
Ensure compliance with product postmarketing approval requirements
Review and approve advertising and promotional items to ensure regulatory compliance
Ensure external communications meet regulations
Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
Job specific responsibilities may include
(choose applicable areas and expand as appropriate); Medical writing
Advertising and promotion
Labeling
Restricted substances reporting as required(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 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 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 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 objectivesestablished 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 objectives
Makes 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 precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
GxPs (GCPs, GLPs, GMPs)
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
Domestic and international regulatory guidelines, policies and regulations
Ethical guidelines of the regulatory profession, clinical research and 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 good problem solving skills
Organize and track complex information
Exercise judgment within broadly defined practices and policies in selecting methods, techniques and 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, identify regulatory scientific data needs and 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.
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 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 exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and Cardiac Rythm Management solutions The Opportunity We areseeking a Regulatory Affairs Project Manager tojoinourCardiacRythm Management teaminSylmar CA. As anindividualcontributor, thefunctionof a Regulatory Affairs Project Manager istocombineknowledgeofscientific, regulatoryandbusinessissuestoenableproductsthataredeveloped, manufacturedordistributedtomeetrequiredlegislation. The individualhasdepartment/group/sitelevelinfluenceandisgenerallyrecognizedasanexpertresourcewithinthedepartment. The individualmayshareknowledgeandexpertisewithothersinsupportofteamactivities. The individualmayidentifydataneeded, obtainthesedataandensurethattheyareeffectivelypresentedfortheregistrationofproductsworldwide. 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 them
Evaluate regulatory risks of division policies, processes, procedures
Provide regulatory input to product lifecycle planning
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes
Assist in regulatory due diligence for potential and new acquisitions
Utilize technical regulatory skills to propose strategies on complex issues
Determine submission 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, review and submit regulatory 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 and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
Evaluate proposed preclinical, clinical and 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 with maintaining annual licenses, registrations, listings and patent information
Ensure compliance with product postmarketing approval requirements
Review and approve advertising and promotional items to ensure regulatory compliance
Ensure external communications meet regulations
Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
Job specific responsibilities may include
(choose applicable areas and expand as appropriate); Medical writing
Advertising and promotion
Labeling
Restricted substances reporting as required(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 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 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 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 objectivesestablished 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 objectives
Makes 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 precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
GxPs (GCPs, GLPs, GMPs)
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
Domestic and international regulatory guidelines, policies and regulations
Ethical guidelines of the regulatory profession, clinical research and 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 good problem solving skills
Organize and track complex information
Exercise judgment within broadly defined practices and policies in selecting methods, techniques and 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, identify regulatory scientific data needs and 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.