Director Regulatory Affairs Operations - Diabetes Care

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.
JOB DESCRIPTION:
For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
This Director Regulatory Affairs Operationswill work for our Diabetes Care Division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
As the Director Regulatory Affairs Operations, you will combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of companies, meet the required legislation. Additionally, the Director will have division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally. This new team member will influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual will plan, direct, coordinate and control the Regulatory Affairs activities related to products worldwide. In addition, this Director will develop and coach a team of regulatory professionals.
WHAT YOU'LL DO

• Responsible for Emerging Issues & Regulations throughout the product lifecycle.
• Responsible for Authorization of Product Release
• Manage processes involved with maintaining annual licenses, registrations, listings and patent information.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation.
• Provides leadership by communicating and providing guidance towards achieving department, division 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.
• Lead and coach a Regulatory Operations team
• Assures the development of multi-level project planning to achieve short and long-term business objectives
• Develops, tracks and reports on all key project deliverables.
• Reviews protocols and reports to support regulatory submissions.
• Prepare and manage software releases

EDUCATION AND EXPERIENCE YOU'LL BRING
Required

• Bachelor's Degree
• 7-10 years' experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.

Preferred

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• M.S. in a technical area or M.B.A. is preferred
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• 7-10 years' experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Strong knowledge of: Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Good understanding of regulatory agency structure, processes and key personnel.
• Regulatory assessment, submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) for hardware and digital products
• Experience providing regulatory support to business partnerships related activities.
• Principles and requirements of promotion, advertising and labeling.
• Principles and requirements of emerging regulations
• Domestic and international regulatory guidelines, policies and regulations.
• Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies.
• Negotiate internally with cross-functional team members and externally with regulatory agencies.
• Must be able to juggle multiple and competing priorities and think analytically with good problem-solving skills.
• Plan and implement most appropriate strategy to obtain product licensure in least amount of time worldwide.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Counsel management on regulatory policies so as to maximize income, minimize competition, and minimize risk to business.
• Direct and manage the preparation of technical strategic regulatory documentation for agency submission.
• Understanding of reimbursement.
• Experience leading and developing a team

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. Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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
The base pay for this position is
$156,400.00 - $312,800.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
United States > Abbott Park : AP52
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf