International Regulatory Affairs Specialist I - Electrophysiology (on-site)

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

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.

The Opportunity

As an individual contributor, the International Regulatory Affairs Specialist I performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.  This new team member will support necessary regulatory activities required for product market entry. This individual will work on-site at our Plymouth, MN location.

What You’ll Work On

• Assists in the preparation of regulatory applications to achieve departmental and organizational objectives, specifically for Asian geographies.
• Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to regulatory management.
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
• Supports change assessment process for regulatory impact within their region of responsibility (mainly Asia for this position)
• Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
• Acts as core team member as needed to provide guidance of applicable regulatory guidelines and project regulatory assessments for international geos.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by worldwide regulatory agencies to various international affiliates.
• May interface directly with regulatory agencies.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with regulations and regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and work experience
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects.         
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 
• Strong organizational and follow-up skills, as well as attention to detail and focus towards improving quality.   
• Multitasks, prioritizes and meets deadlines in timely manner.      

Preferred Qualifications

• Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics). 
• Master’s degree
• Experience working in a broader enterprise/cross-division business unit model.
• Experience working in the Medical Device industry.
• Regulatory Affairs Professionals Society Certification is a plus.
• Additional language skills including Chinese, Korean, or other Asian languages.
• Flexibility to work later hours for global meetings.

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

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.

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The base pay for this position is $50,700.00 – $101,300.00. In specific locations, the pay range may vary from the range posted.