Abbott Senior Regulatory Affairs Specialist 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.
We are seeking an experienced, high caliber Senior Regulatory Affairs Specialist. This position leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems. Provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Prepares robust regulatory applications to achieve departmental and organizational objectives
Creates, reviews and approves engineering change orders
Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team
Provides guidance and expertise
Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail
Maintains ongoing surveillance and analysis of all 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
Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations - Interfaces directly with FDA and other regulatory agencies
Supports the product release process by creating licenses or reviewing and approving requests for product release
Conducts reviews of product and manufacturing changes for compliance with applicable regulations - Reviews protocols and reports to support regulatory submissions
BA or BS degree; technical discipline preferred
A minimum of 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry
Experience working with Class III Medical Devices (Transcatheter valve experience is a plus)
Experience with IDE supplements, PMA supplements and US device regulations and experience with EU and other international medical device regulations and submissions
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Ability to travel approximately 10%
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
TRAVEL UP TO 10% - SOME INTERNATIONAL TRAVEL.
OPEN TO CONSIDER CANDIDATES AT LOWER LEVEL.
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 email@example.com