Regulatory Affairs Intelligence Specialist

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 is 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.

WHO WE WANT

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement with processes.
• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure deliverables are complete in meeting regulations and expectations.

WHAT YOU’LL DO

Global Regulatory Operations is seeking a Regulatory Affairs Intelligence Specialist to join our team in Plymouth, MN.

This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices. Assisting in the process to evaluate proposed regulatory changes in major markets including the US, EU, Canada, Australia, Brazil, Japan, the Regulatory Affairs Intelligence Specialist:

• Supports the maintenance of, or continuous improvement of quality system procedures, and documents
• Monitors and fact-checks new or changing global regulations
• Supports the communication of emerging regulations, documents for comment, and regulations in implementation
• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Performs regulatory investigations to assess medical device regulatory changes within a specific country or region
• Performs other related duties and responsibilities, on occasion, as assigned
• May train others on systems and processes
• Tracks and documents regulations within the regulatory intelligence systems
• Gathers additional data to support interpretation, and aid businesses in determining impact
• Facilitates the collection and reporting of data in support of key performance indicators
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, etc.
• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s degree (or equivalent)
• Proficient in Excel, and all programs with MS Office suite (Word, PowerPoint, Outlook)
• Strong verbal and written communication skills · Strong attention to detail and organizational skills
• Experience in program management a plus
• 2-5+ years’ experience in Medical Devices, or a regulated industry (e.g., nutritional, pharma) preferred. Experience in a Regulatory or Quality role, a plus.
• Experience with document management systems a plus
• Ability to work within a fast-paced and matrixed team environment

WHAT WE OFFER

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

• 401(k) retirement savings with a generous company match
• Financial security through competitive compensation, incentives and retirement plans
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities
• Training and career development, with onboarding programs for new employees and tuition assistance
• Paid time off
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• A fast-paced work environment where your safety is our priority

Apply Now

• 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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 $56,700.00 – $113,300.00. In specific locations, the pay range may vary from the range posted.