Hybrid Senior Regulatory Affairs Manager

at Abbott

• Job title: Senior Regulatory Affairs Manager
• Job type: Full Time
• Experience level: Senior
• Salary: $111,300 - $222,700 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Lake Forest, United States

About the role

• Senior Regulatory Affairs Manager at Abbott managing compliance and regulatory strategies for medical products. Leading project management and regulatory submissions in the healthcare sector.

Responsibilities

• Provide regulatory affairs project management for various areas, to include 510(k), CLIA Waiver, label/advertising/promotional review, and other regulatory compliance activities.
• In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets.
• Coordinate preparation of well organized, complete and scientifically sound regulatory submissions.
• Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
• Exercise judgement within generally defined practices and departmental standard operating procedures.
• Develop and maintain strong and effective relations with internal/external personnel.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Advises development and/or marketing teams on manufacturing changes, technical labeling, appropriate regulations and interpretations.
• Keep abreast of regulatory requirements in the US and countries where the Division intends to offer product for sale.

Requirements

• Bachelor's Degree Preferably in scientific or engineering related disciplines or an equivalent combination of education and work experience
• At least 6 years or more of experience in a similar role in similar organization.
• Advanced degree or additional professional training in regulatory affairs (RA) desired.
• At least 3 years of experience with molecular and lateral flow assays
• Must have well developed written, oral, interpersonal and negotiation skills.
• Leadership competency including organizational development and project management skills.

Benefits

• 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.