Regulatory Affairs Specialist II

International Regulatory Affairs Specialist Ii

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

In Abbott's Electrophysiology (EP) business, we are 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.

We are currently hiring an International Regulatory Affairs Specialist II to work on-site at our Plymouth, MN location. 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 Chinese regulatory applications to achieve departmental and organizational objectives.

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 ( 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience.

Master's Degree ( 18 years), preferred.

2-3 years' experience in a regulated industry (e.g., medical products, nutritional). Regulatory area is preferred but may consider quality assurance, research and development / support, scientific affairs, operations, or related area.

Experience with 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; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note : This knowledge may be developed through tenure in this position.

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.

Write and edit technical documents.

Negotiation skills.

Strong attention to detail.

Manage projects. Create project plans and timelines.

Think analytically and critically.

Organize and track complex information.

Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Has a sound knowledge of a variety of alternatives and their impact on the business.

Apply business and regulatory ethical standards.