Sr. Regulatory Affairs Manager

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 114000 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 your family be your true self and live a full life. Youll also have access to :

Career development with an international company where you can grow the career you dream of.

Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

An excellent retirement savings plan with a high employer contribution

Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.

A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.

The Opportunity

The Sr. Regulatory Affairs Manager hired in this role will work out of the Lake Forest IL (or ourTown Center San Diego CA) location 4-5 days a week in the office. This role will require some travel up to 25% to Abbott locations potentially in and outside of the US. This is part of the Infectious Diseases Division at Abbott Rapid Diagnostics. This role reports to the leader that also leads Global New Product Introductions and US Regulatory. Were empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day more than 10 million tests are run on Abbotts diagnostics instruments providing lab results for millions of people.

What you will do

Provide regulatory affairs project management for various areas to include 510(k) CLIA Waiver label / advertising / promotional review and other regulatory compliance collaboration with the Regulatory leadership develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets.

In addition the person hired will :

Coordinate preparation of well organized complete and scientifically sound regulatory submissions.

Interface directly with various regulatory agencies as required to facilitate the review and approval of regulatory applications.

Exercise judgement within generally defined practices and departmental standard operating procedures.

Develop and maintain strong and effective relations with internal / external personnel.

Interacts with regulatory agency to expedite approval of pending registration.

Serves as regulatory liaison throughout product lifecycle.

Participates in some of the following : product plan development and implementation regulatory strategy risk management.

Serves as regulatory representative to marketing research teams and regulatory agencies.

Advises development and / or marketing teams on manufacturing changes technical labeling appropriate regulations and interpretations.

Keep abreast of regulatory requirements in the US and countries where the Division intends to offer product for sale.

Work with the Regulatory leadership to prepare regulatory plan / strategy for product introductions.

Manage the preparation of registration documents as required for international markets.

Ensure that submissions are complete properly formatted and comply with applicable regulatory requirements.

Make certain that appropriate documentation is maintained to record regulatory decisions made in design and development activities.

Minimum Qualifications :

Bachelors Degree Preferably in scientific or engineering related disciplines or an equivalent combination of education and work experience

At least 6 years or more of experience in a similar role in similar organization.

Preferred Qualifications

Advanced degree or additional professional training in regulatory affairs (RA) desired.

At least 3 years of experience with molecular and lateral flow assays

Must have well developed written oral interpersonal and negotiation skills.

Leadership competency including organizational development and project management skills.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives :

Follow 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.

Connect with us at on Facebook at and on Twitter @AbbottNews.

The base pay for this position is

$111300.00 $222700.00

In specific locations the pay range may vary from the range posted.

JOB FAMILY :

Regulatory Operations

DIVISION :

ID Infectious Disease

LOCATION : United States >

Lake Forest : J55

ADDITIONAL LOCATIONS :

United States >

San Diego : 4545 Towne Center Court

WORK SHIFT : Standard

TRAVEL : Yes 25 % of the Time

MEDICAL SURVEILLANCE :

No

SIGNIFICANT WORK ACTIVITIES :

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Driving a personal auto or company car or truck or a powered piece of material handling equipment 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 :

EEO is the Law link - Espanol : Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 111300 - 222700