International Regulatory Affairs Specialist II – Electrophysiology (on-site)

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.

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN.  This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission review of documentation for International geographies (primarily China) regulatory registration, ensuring products and procedures comply with regulations. Additionally, will support necessary regulatory activities required for product market entry. 

• Assist in the preparation of regulatory applications to achieve departmental and organizational objectives, focused on China. 
• Review applicability of medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission database and file systems.  Ensure that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested. 
• Determine and communicate submission and approval requirements and timelines to project teams. 
• Evaluate proposed preclinical, clinical, design and manufacturing changes for regulatory submission strategies. 
• Track deliverables to meet timelines and follow up as needed to ensure timelines are met. 
• Provide Regulatory impact assessment for changes to already licensed products. 
• Act as a regulatory representative responsible for review and analysis of applicable regulatory guidelines. 
• Work across functions to develop documents or required product information for successful regulatory submission. 
• Assist with label development and review for compliance before release.
• Support the product release process by reviewing and approving requests for product release. 
• Exercise judgment in selecting innovative, practical methods to achieve problem resolution. 
• Support 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. 

• Bachelor’s degree (or equivalent)
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, clinical, or related area. Note: Higher education may compensate for years of experience.  
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Flexible schedule to attend meetings as needed with affiliates in other geographies.
• Strong problem-solving skills and ability to think strategically and see the big picture. 

• Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields. 
• Master’s degree.
• Experience with medical device industry. 
• Experience working with NMPA (CFDA) or other international regulatory parties. 
• Chinese/Mandarin speaking candidate. 
• Experience working in a broader enterprise/cross-division business unit model. 
• Adaptable with the ability to switch priorities and accomplish all tasks. 
• Process oriented.  
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  

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