22h ago

New

Director, Regulatory Affairs

United States - Illinois - Abbott Parkexecutive

OtherRegulatory Affairs

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Quick Summary

Key Responsibilities

Gather, assess, summarize, and disseminate available regulatory information, such as proposed rules and guidance Develop in conjunction with relevant internal stakeholders, draft,

Requirements Summary

Identify for stakeholders new regulatory requirements to ensure company-wide compliance Advance the organization’s position by participating and taking leadership roles in professional associations,

Technical Tools

OtherRegulatory Affairs

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 122,000 colleagues serve people in more than 160 countries.

What We Offer

~2 min read

Regulatory Intelligence:

✓Gather, assess, summarize, and disseminate available regulatory information, such as proposed rules and guidance

✓Develop in conjunction with relevant internal stakeholders, draft, and submit directly to regulatory agencies and trade associations the Abbott position/response to proposed device regulatory policy

✓Implement processes for monitoring and communicating emerging regulatory issues

✓Lead cross-business regulatory council consisting of business regulatory heads, legal, government affairs, and AQR

✓Chair or co-chair council committees designed to execute objectives defined by the regulatory council, such as global conference, emerging issues, talent management

✓Work across businesses, government affairs, and legal to define, develop, and obtain consensus on Abbott regulatory positions on critical regulatory proposals

✓Develop and maintain communication strategies for efficient and effective means of cross business information sharing

✓Anticipate regulatory emerging issues and develop solutions to them

✓Identify need for new regulatory policies/processes

✓Develop solutions to address emerging regulatory issues with other members of management and stakeholders

✓Develop corporate positions on regulatory risk-benefit

✓Create and develop positions and strategies based upon proposed regulatory requirements

✓Identify for stakeholders new regulatory requirements to ensure company-wide compliance

✓Advance the organization’s position by participating and taking leadership roles in professional associations, industry and trade groups and appropriate standards organizations

✓Advise management and stakeholders on regulatory issues

✓Manage communication and negotiation with regulatory authorities and lobbying government leaders

✓Utilize expert technical regulatory skills to influence regulators on complex issues

✓Consult with and advise businesses on regulatory issues

✓Participate in the development of new regulations, guidelines and/or standards to promote scientific innovation balanced with appropriate safety concerns

Responsibilities

~1 min read

→Provides leadership without direct authority (i.e., project leader); includes 1 direct report

Corporate-wide strategies and programs
External and internal regulatory advocacy
Recognized as a key opinion leader and resource in regulatory affairs
Develops, communicates, and builds consensus for goals that are in alignment with the corporation.
Provides leadership by communicating and providing guidance towards achieving cross-business and/or corporate objectives.
Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.
Leads multiple cross-business committees/teams
Acts as a mentor to less-experienced staff internal and external to the department/division.
Exercises judgment independently.

Requirements

~1 min read

Bachelor's degree
7-10 years of experience in a regulated industry (e.g., medical device, pharmaceutical, nutritional/food products)
Knowledge of how agency regulations and guidance are developed
Negotiate internally and externally with regulatory agencies
Work with cross-functional teams
Demonstrated analytical, strategic-thinking, and problem-solving skills
Communicate effectively verbally and in writing to diverse audiences and personnel
Write and edit regulatory documents; persuasive writing
Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and regulatory agencies
Able to juggle multiple and competing priorities

Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields
Advanced degree (MS in technical area, PhD, Law)
7-10 years of experience in regulatory preferred, but may consider quality assurance, research and development/support, scientific affairs, operations, or related area

APPLY NOW

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

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

$171,300.00 – $342,700.00

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

Regulatory Operations

AQR Abbott Quality and Regulatory

United States > Abbott Park : AP52

Standard

Yes, 20 % of the Time

Not Applicable

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