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Associate Director - Regulatory Affairs

at Abbott in Lake Forest, Illinois, United States

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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. Our pioneering technology spans the world of healthcare operations – with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

The Opportunity:

Our location in Lake Forest (Lake County), Illinois currently has an opportunity for an Associate Director, Regulatory Affairs within our Core Diagnostics division.

MAIN RESPONSIBILITIES

The Associate Director, Regulatory Affairs role will provide leadership and supervision to regulatory affairs staff, combining knowledge of regulatory, technical, Quality System and business practices to ensure that products meet US-FDA and worldwide regulatory requirements. The role individual has division level influence and is generally recognized as an expert resource both within Abbott and externally. Specifically, the individual will oversee development of new products, lead the writing and submission of 510k and PMA submissions, provide guidance to the Core Diagnostics team on regulatory filings and responses, and provide critical regulatory intelligence and guidance back to the business. This will include partnering with key internal stakeholders, interfacing with internal/external SMEs, and partnering with both cross-divisional and corporate regulatory affairs colleagues to ensure the scientific data and submissions fulfills agency expectations.

The Associate Director will:

+ Provide leadership to develop and execute global regulatory strategies that include emerging regulations, regulatory authority/institution updates, regulatory advocacy and trade association interactions.

+ Provide strategic input and technical guidance on regulatory requirements to product development teams and ensures preapproval compliance activities are completed.

+ Negotiate with regulatory authorities during the product development and submission review process to ensure agency requirements are understood and addressed, leading to submission clearance/approval.

+ Develop and presents options and solutions to regulatory obstacles and emerging issues.

+ May participate in applicable trade association/industry working groups to influence policy/rule-making in alignment with business strategies and evolving science.

+ Drive and support the decision-making process to understand and prioritize the regulatory risks and opportunities globally including frequent communication to various internal management stakeholders of regulatory strategies and internal impact analyses.

+ Remain current on developments in field(s) of expertise, emerging regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions and Quality Systems. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.

+ Identify need for new regulatory policies, processes and SOPs.

+ Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), and other regulatory requirements.

+ May manage small staff, in which case the individual is expected to hire and retain a diverse, highly qualified staff, provide ongoing performance feedback, and maintain a safe and professional work environment.

+ Be responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Minimum Qualifications

+ Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

+ Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

+ 5-7 years of experience in regulatory affairs preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Preferred Qualifications

+ M.S. or Ph.D. in a technical area

+ Extensive experience in developing both US and global regulatory strategies

+ Significant experience interacting and negotiating with the US FDA

+ Knowledge of IVD Diagnostic products

+ Experience in Quality systems

+ Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment.

WHAT WE OFFER

+ At Abbott, you can have a good job that can grow into a great career. We offer:

+ Training and career development , with onboarding programs for new employees and tuition assistance

+ Financial security through competitive compensation, incentives and retirement plans

+ Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

+ Paid time off

+ 401(k) retirement savings with a generous company match

+ Pension Plan (exceptions may apply)

+ The stability of a company with a record of strong financial performance and history of being actively involved in local communities

The base pay for this position is $118,000.00 – $236,000.00. In specific locations, the pay range may vary from the range posted.

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

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Job Posting: JC240436694

Posted On: May 18, 2023

Updated On: Sep 22, 2023

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