Abbott Regulatory Affair Project Manager in St. Paul, Minnesota
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.
Develops sound global regulatory strategies for new and modified medical devices.
Prepares robust regulatory applications to achieve departmental and organizational objectives.
Creates, reviews and approves engineering changes.
Provides leadership and guidance (including training) to other members of the RA staff.
Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
Provides Regulatory leadership to development teams:
Provides global strategic input (including all feasible alternatives and associated risks).
Drives cross functional alignment with issues that could have Regulatory ramifications.
Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies).
Builds strategic partnerships to further departmental and organizational objectives.
Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control).
Reviews protocols and reports to support regulatory submissions.
Assesses proposed regulations and communicates new requirements to the organization.
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) and international regulations, 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.
Assists with audits and inspections, if required.
BA or BS degree (degree in a technical discipline highly preferred).
Minimum 6 years regulatory experience; 8 years preferred.
Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 5%, including internationally.
Ability to maintain regular and predictable attendance.
Ability to work independently with no oversight.
Ability to identify and solve problems in a strategic manner.
Ability to manage complex projects.
Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.
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 firstname.lastname@example.org