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 109,000 colleagues serve people in more than 160 countries.
A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in SYLMAR, CA OR SCOTTSDALE, AZ OR LIBERTY, SC currently has an opportunity for a Senior Specialist Regulatory Affairs. 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.
WHAT YOU’LL DO
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Prepares robust regulatory applications to achieve departmental and organizational objectives.
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Creates, reviews and approves change orders.
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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.
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Acts as a liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
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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. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
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Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
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Interfaces directly with FDA and other regulatory agencies.
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Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
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Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
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Reviews protocols and reports to support regulatory submissions.
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Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
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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.
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Provides mentoring and leadership to Regulatory Specialist I and II team members
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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Bachelors Degree in a related technical or science field
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Minimum 5 years of Technical experience, including at least 4 years of regulatory experience in a medical device industry.
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Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
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Expertise with EDMS (Documentum based), publishing and or registration management systems, Adobe Acrobat or demonstrated experience with similar tools.
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Ability to work in a highly matrixed and geographically diverse business environment.
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Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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Ability to leverage and/or engage others to accomplish projects.
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Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
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Multitasks, prioritizes and meets deadlines in timely manner.
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Strong organizational and follow-up skills, as well as attention to detail.
Preferred
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Experience working in a broader enterprise/cross-division business unit model preferred.
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Expertise with electronic submission formats like eCTD, ACTD and NeeS.
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Ability to travel approximately 5%, including internationally.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.