Director, Regulatory Affairs

Director, Regulatory 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 115,000 colleagues serve people in more than 160 countries.

The Opportunity

The Director, Regulatory Affairs provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct activities associated with capturing domestic and international information both internal and external that impacts the quality, regulatory, and compliance areas of Abbott and keep management abreast of regulatory changes and the impact they could have on the organization.

Also, this person will direct and manage cross-business regulatory activities designed to address emerging regulatory issues, incorporate strategic action, and advance the development of Abbott regulatory professionals. This person will be a subject matter expert in the regulatory area organization and serve as a resource that others within the organization can approach for guidance.

What You'll Work On

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

Cross-Business Initiatives:

• 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

Strategic Planning:

• 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

Influence:

• 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

Supervisory / Management Responsibilities

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

Position Accountability / Scope

• 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.

Required Qualifications

• 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

Preferred Qualifications

• 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