International Regulatory Affairs Specialist II Electrophysiology (on-site) at Abbott

Regulatory Affairs Specialist II

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.

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

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.

What You'll Work On

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.)

The base pay for this position is $61,300.00 $122,700.00. In specific locations, the pay range may vary from the range posted.