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 currently has an opportunity for a Regulatory Affairs Specialist II. The Regulatory Affairs Specialist II performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.
Experienced professional individual contributor that works under supervision.
Applies subject matter knowledge in the area of Regulatory Affairs.
Requires capacity to apply skills/knowledge within the context of preparation, and submission of documentation for worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
WHAT YOU’LL DO
As the experienced professional in Regulatory Affairs, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Serves as regulatory liaison throughout product lifecycle.
Participates as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
Reviews protocols and reports to support regulatory submissions.
Ensures timely approval of medical devices and continued approval of marketed products.
May interact with regulatory agency to expedite approval of pending registration.
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
Maintains knowledge of pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current and up-to-date.
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS) 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
Associates Degree Minimum 1 year experience with medical device regulation Experience with regulatory submissions to US FDA or EU Notified Body preferred.
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.
Preferred
Bachelors Degree in a Technical Discipline preferred
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career.
We offer:
Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match 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.