Jobs

International Regulatory Affairs Manager

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.

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.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

At Abbott, we offer a portfolio of products with the versatility to diagnose and manage an array of cardiac arrhythmias. These products include complete portfolio of EP catheters and capital products along with implantable devices designed to improve outcomes and reduce heart failure. Responsible and visionary clinical leadership helps us reduce the cost of health care, lessening the impact of epidemic disease on patients and their families. Our clinical successes allow us to offer an unparalleled portfolio of cardiac arrhythmia management products.

Abbott is seeking a passionate, experienced INTERNATIONAL REGULATORY AFFAIRS MANAGER to join our team in the greater Minneapolis, MN area.  In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required regulations for Latin America, South America, Eastern Europe, Middle East, and Africa.  In this role, you will have the opportunity to develop, implement and lead a team for our Electrophysiology division.

WHAT YOU’LL DO

• Develop new regulatory policies, processes and SOPs and train key personnel on them.  Evaluate regulatory risks of division policies, processes, procedures. Recruit, develop and manage regulatory professionals.
• Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
• Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the division. · Provides leadership by communicating and providing guidance towards achieving department objectives
• Help to develop regulatory strategy for Class III and Class II medical devices, with other regulatory team members
• Manage and execute preapproval compliance activities Post market. Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements.
• Creates immediate to long-range plans to carry out objectives established by top management

EDUCATION AND EXPERIENCE YOU’LL BRING

REQUIRED:

• Bachelor’s degree (or equivalent)
• 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
• Regulatory Knowledge of (as applicable):

Regulatory history, guidelines, policies, standards, practices, requirements and precedents

Regulatory agency structure, processes and key personnel

Principles and requirements of applicable product laws

Submission/registration types and requirements · GxPs (GCPs, GLPs, GMPs)

Principles and requirements of promotion, advertising and labeling

International treaties and regional, national, local and territorial trade requirements, agreements and considerations

Domestic and international regulatory guidelines, policies and regulations

Ethical guidelines of the regulatory profession, clinical research and regulatory process

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

• Communication Skills or Ability to:

Communicate effectively verbally and in writing

Communicate with diverse audiences and personnel

Write and edit technical documents

Work with cross-functional teams

Work with people from various disciplines and cultures

Negotiate internally and externally with regulatory agencies

Plan and conduct meetings

• Cognitive Skills or Ability to:

Strong attention to detail

Manage projects

Create project plans and timelines

Must be able to juggle multiple and competing priorities

Think analytically with good problem-solving skills

Organize and track complex information

Has broad knowledge of various technical alternatives and their potential impact on the business

Exercises good and ethical judgment within policy and regulations

Uses in-depth knowledge of business functions and cross group dependencies/ relationships

Possesses ability to define regulatory strategy

Able to follow scientific arguments, identify regulatory scientific data needs & solve regulatory issues

Perform risk assessment or analysis

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.)
• Previous experience in the medical device industry, including experience with Class II or Class III medical device submissions to regulatory agencies
• Experience with regulations in these geographies (Latin America, South America, Eastern Europe, Middle East, and Africa)
• Managerial/Leadership experience

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 here

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

Job posted: 2023-04-25