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Abbott Regulatory Affairs Project Manager, Digital Product Development in Alameda, California

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 103,000 colleagues serve people in more than 160 countries.

This is a unique, new Regulatory Affairs Project Manager position at ADC (Abbott Diabetes Care) where you will focus on our recent digital business partnerships. You will manage the relationships with external and internal stakeholders, provide regulatory strategies, road map planning, and evaluate regulatory impact assessments. You will work to identify creative pathways in different markets and also deliver on submissions and negotiate with regulatory bodies.

Examples of business partnerships include our partnerships with Bigfoot Biomedical and Novo Nordisk. These partnerships are related to enhancements for our FreeStyle Libre medical device products.

We are looking for someone with PMA, IDE or 510(K) submissions experience. Software medical device experience would be a nice to have, as would experience partnering with marketing, commercial, business development and R&D teams, and project management.

Official Qualifications:

BS/BA degree required, preferably in scientific or engineering related disciplines or combined relevant years of education and work experience in regulatory affairs. Advanced degree or additional professional training in regulatory affairs (RA) desired. Requires a minimum of 4 years RA experience, including oversight of submissions for new products and product changes in the health care industry and/or medical devices industry. Some of the required 4 years overall RA experience can be substituted with experience in a scientific/technical role in the health care industry and/or medical device industry (ideally). Must have well developed written, oral, interpersonal and negotiation skills Leadership competency including organization development and project management skills.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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