Regulatory Affairs Project Manager

locations

United States - California - Sylmar

time type

Full time

posted on

Posted 30+ Days Ago

job requisition id

31117759

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.

JOB 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, 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 M anagement solutions

The 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 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

D evelop 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

J ob specific responsibilities may include (choose applicable areas and expand as appropriate) ;

Medical writing

Advertising and promotion

Labeling

R estricted 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 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 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 Prod uct 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.

JOB FAMILY :

Regulatory Operations

DIVISION :

CRM Cardiac Rhythm Management

LOCATION : United States >

Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS :

WORK SHIFT :

Standard

TRAVEL : Yes, 5 % of the Time

MEDICAL SURVEILLANCE :

No

SIGNIFICANT WORK ACTIVITIES :

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) 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.pdf EEO is the Law link - Espanol : http : / / webstorage.abbott.com / common / External / EEO_Spanish.pdf