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About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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 will have access to:

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

• 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.

Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

The Opportunity

As a manager, the function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data are identified, obtained and effectively presented for the registration of products worldwide.

CORE JOB RESPONSIBILITIES

• Identify need for new regulatory policies, processes and SOPs and approve them.

• Evaluate regulatory risks of corporate policies.

• Provide strategic guidance for product development and planning throughout the product lifecycle.

• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.

• Develop global regulatory strategies for product development and commercialization, update based upon regulatory changes.

• Lead regulatory risk assessments and mitigation strategies.

• Conduct regulatory due diligence for potential and new acquisitions and advise management.

• Utilize technical regulatory skills to propose strategies on complex issues.

• Lead crisis management program development and implementation.

Recruit, develop and manage regulatory professionals.

• Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges.

• Review and approve labeling to ensure compliance.

• Represent regulatory affairs in product recall and recall communication process.

• Provide strategic input and technical guidance on regulatory authority queries.

• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.

• Negotiate internally and externally with regulatory agencies and participate in political lobbying.

• Create project plans and timelines.

• Lead functional groups in the development of relevant data to complete a regulatory submission.

• Develop and communicate a vision for the organizational unit assigned.

• Provide technical leadership to business units.

• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.

• Negotiate with regulatory authorities during the development during the development and review process to ensure submission approval.

• Monitor and interpret regulatory requirements and communicate changes to relevant stakeholders.

• Evaluate performance of and assists in career development planning for subordinates.

• Write and edit technical documen

QUALIFICATIONS

Bachelors Degree (± 16 years) Science, math or medical fields preferred.

Masters Degree (± 18 years) MS in technical area or MBA is preferred.

EXPERIENCE

Minimum 5-7 years leadership experience in a regulated industry.

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com