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 portfolio of innovative solutions is designed to provide customers greater freedom and better health,
Our location in SYLMAR, CA currently has an opportunity for a Manager, Regulatory Affairs – Remote Care. The Manager, Regulatory Affairs – Remote Care is responsible for strategy and execution of global regulatory activities related to the Programmer Hardware and Software and Remote Monitoring. This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs submissions and approvals through collaboration with various functions within the Business Unit (including, but not limited to Regulatory Affairs, Research and Development, Quality, and Global Marketing), as well as affiliate Regulatory Affairs departments.
The Manager Regulatory Affairs – Remote Care is responsible for tactical and operational activities, as well as managing the work priorities and career development of direct reports who are focused on tactical, operational and some strategic activities pertaining to obtaining and maintaining global regulatory product approvals. Management responsibilities include managing performance, developing talent, driving engagement and inclusion, communicating business and operational requirements, and project planning.
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 engineering changes.
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Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
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Reviews and evaluates communications to ensure all necessary details adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies.
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Maintains 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 information of regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
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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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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 global regulations and 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.
EDUCATION AND EXPERIENCE, YOU’LL BRING
Required
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Bachelors Degree (± 16 years) or an equivalent combination of education and work experience
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Related experience with medical device development and/or hardware, software, digital health, remote care
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Experience with US submissions (510(k), PMA, PMA Supplements, IDEs) and/or EU submissions (EU MDR Technical Documentation) preferred
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Ability to travel approximately 5-10%, including internationally.
Preferred
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Master’s degree preferred
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Experience with active implantable medical devices and connected systems
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Experience working in a broader enterprise/cross-division business unit model preferred.
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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. 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. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
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.