Abbott Regulatory Affairs Project Manager in Irvine, California
At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
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.
Performs other related duties and responsibilities, on occasion, as assigned.
Minimum 10 years experience in US/EU regulatory submissions for Class 3 PMA products with success in FDA/EU product submission and approvals
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
ASJM Abbott St. Jude Medical
United States > Sylmar : 15900 Valley View Court
United States > Sunnyvale : 645 Almanor Ave
Yes, 15 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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