Regulatory Affairs Specialist II – Electrophysiology (on-site)

Abbott • Maple Grove, MN

47d • $60,000 - $120,000 • Onsite

About The Position

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform 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. Supports necessary regulatory activities required for product market entry.

Requirements

• Bachelor’s degree or an equivalent combination of education and work experience
• 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, 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.

Nice To Haves

• Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields.
• Master’s degree in Regulatory Affairs.
• Regulatory experience with capital equipment including software, firmware, graphical user interfaces, and associated hardware.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Responsibilities

• Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives.
• Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.
• Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
• Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
• Supports the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers.
• May interface directly with FDA and other regulatory agencies if so directed.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other 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.
• Performs other related duties and responsibilities as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees