Abbott

Regulatory Affairs Coordinator

Abbott • $102K *
Sylmar, CA 91342In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Technical Diploma or equivalent experience (12 years minimum)
  • 1 year of experience in regulatory affairs or a related field
  • Associate's or Bachelor's degree in a technical area preferred
  • Experience in a regulated business environment preferred
  • Project Management skills and familiarity with PLM systems like Windchill preferred

Responsibilities

  • Ensure compliance with Corporate and Divisional policies
  • Execute global regulatory assessments
  • Analyze and track Product Release Authorizations
  • Develop and improve regulatory processes
  • Collaborate with cross-functional teams for regulatory inputs
  • Maintain legislative and regulatory records
  • Assist with submission preparation and market release processes

Benefits

  • Opportunity to work with a global leader in Cardiac Rhythm Technologies
  • On-site position in Sylmar, California
  • Engagement in cross-functional collaboration
  • Experience in a highly regulated industry
  • Development of skills in regulatory processes and project management
Full Job Description
JOB DESCRIPTION:

Job Description

The Opportunity

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

ThisRegulatory Affairs Coordinatorwill work on-site at our Sylmar, CA location in the Cardiac Rhythm Management Division. This new team member will provide administrative support for regulatory processes and procedures. The individual may coordinate and support technical and scientific regulatory activities, researchregulationsand guidance, and organize andmaintainkey information sources.

WhatYoullWork On

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Strategic Planning:

  • Execute global regulatory assessment

  • Analyze, plan, execute and track Product Release Authorizations

  • Develop,analyzeand execute on improvements to regulatory processes

  • Collaborate cross functionally for inputs to regulatory processes

  • SOP and other document maintenance

  • Maintain records on legislation,regulationsand guidelines

  • Assistin monitoring and reporting project timelines

Premarket:

  • Secure global regulatory assessments for input into global regulatory strategy

  • Assistin the releasing of product to market

  • Assistin the compilation and organization of materials forpresubmissionreports

  • Assistin the preparation of submission/registration packages

  • Assistin the organization of materials from preclinical and clinical studies for review

  • Assistin notarization of documents

Postmarket:

  • Update andmaintainpaper/electronic document regulatory files and archival systems

  • Assistin the preparation of routine reports and regulatory agency communications

  • Assistwith internal audits and inspections

  • Assistin the preparation ofpostmarketreports and submissions

  • Update andmaintainglobal product listings, facility registrations, licenses/approvals, and annual registrations.

Required Qualifications

  • Technical Diploma ( 12 years)

  • Minimum1 yearrelated experience

Preferred Qualifications

  • Associate's or Bachelor'sdegree in a technical area (such as biology, chemistry, engineering, microbiology, immunology, medical technology, pharmacy)

  • Experience in a regulated business environment (e.g., legal office, regulated industry).

  • Project Management skills

  • Experience with Windchill or other PLM system

The base pay for this position is

$24.65 6 $49.35/hour

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Regulatory Operations

DIVISION:CRM Cardiac Rhythm Management

LOCATION:United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:No

MEDICAL SURVEILLANCE:No

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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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