Director, Regulatory Affairs

Abbott • Chicago, IL

1d • $171,300 - $342,700

About The Position

The Director, Regulatory Affairs provides leadership, direction, and support for regulatory policy and cross-business regulatory initiatives at Abbott. The role influences changing regulations and guidance through participation in trade associations and engagement with regulatory agencies. It directs the capture of domestic and international information affecting Abbott’s quality, regulatory, and compliance areas, and keeps management informed about regulatory changes and their potential organizational impact.

The Director manages cross-business regulatory activities addressing emerging issues, incorporating strategic action, and advancing the development of regulatory professionals. The role serves as a regulatory subject matter expert and resource across the organization. It has corporate-wide scope, leads multiple cross-business committees and teams, mentors less-experienced staff, exercises independent judgment, and provides leadership toward cross-business and corporate objectives. The position includes one direct report and leadership without direct authority. It is based at Abbott Park in the United States, with travel of approximately 20% of the time.

Requirements

• Bachelor’s degree.
• 7–10 years of experience in a regulated industry, such as medical devices, pharmaceuticals, or nutritional/food products.
• Knowledge of how agency regulations and guidance are developed.
• Ability to negotiate internally and externally with regulatory agencies.
• Experience working with cross-functional teams.
• Demonstrated analytical, strategic-thinking, and problem-solving skills.
• Effective verbal and written communication skills for diverse audiences and personnel.
• Ability to write and edit regulatory documents, including persuasive writing.
• Ability to prepare and present written and oral reports and presentations to internal and external audiences, including senior management and regulatory agencies.
• Ability to manage multiple and competing priorities.

Nice To Haves

• Bachelor’s degree in a science field (biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology), mathematics, engineering, or a medical field.
• Advanced degree, such as an MS in a technical area, PhD, or law degree.
• 7–10 years of regulatory experience preferred; experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may also be considered.

Responsibilities

• Gather, assess, summarize, and disseminate regulatory information, including proposed rules and guidance.
• Work with internal stakeholders to draft and submit Abbott positions or responses to proposed device regulatory policy to regulatory agencies and trade associations.
• Implement processes for monitoring and communicating emerging regulatory issues.
• Lead a cross-business regulatory council comprising business regulatory heads, legal, government affairs, and AQR.
• Chair or co-chair council committees established to execute objectives, including committees focused on global conferences, emerging issues, and talent management.
• Work across businesses, government affairs, and legal to define, develop, and build consensus on Abbott positions concerning critical regulatory proposals.
• Develop and maintain strategies for effective cross-business information sharing.
• Anticipate emerging regulatory issues and develop solutions with management and stakeholders.
• Identify the need for new regulatory policies or processes and develop corporate positions on regulatory risk-benefit and proposed requirements.
• Identify new regulatory requirements for stakeholders to support company-wide compliance.
• Represent and advance Abbott’s position in professional associations, industry and trade groups, and standards organizations, including taking leadership roles.
• Advise management, stakeholders, and businesses on regulatory issues.
• Manage communications and negotiations with regulatory authorities and lobby government leaders.
• Use technical regulatory expertise to influence regulators on complex issues.
• Participate in developing regulations, guidelines, and standards that balance scientific innovation with appropriate safety concerns.
• Communicate and build consensus for goals aligned with the corporation, provide guidance toward corporate and cross-business objectives, and coordinate activities across organizational units.
• Mentor less-experienced staff inside and outside the department or division.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit providing a path to a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Director