Abbott

Senior Regulatory Affairs Specialist - Heart Failure (on-site)

Abbott • $90K — $180K *
Pleasanton, CA 94566In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a related field or equivalent education and experience
  • 3-4 years in a regulated industry like medical products or nutritionals
  • 2-3 years in regulatory affairs preferred, with consideration for related fields
  • Excellent verbal and written communication skills, especially with regulatory agencies
  • Strong organizational skills and keen attention to detail
  • Capable of managing complex information effectively

Responsibilities

  • Develop worldwide regulatory strategies for product approvals
  • Prepare regulatory submissions for FDA and international agencies
  • Represent Regulatory Affairs in cross-functional product development teams
  • Maintain licenses and registrations while ensuring compliance with post-marketing requirements
  • Act as a Subject Matter Expert during audits and inspections
  • Review and approve advertising and promotional materials
  • Interface with regulatory agencies and facilitate communications with in-country affiliates

Benefits

  • Comprehensive health and wellness benefits
  • Opportunities for career advancement and professional growth
  • Support for a work-life balance
  • Participation in company initiatives supporting quality and environmental management systems
  • Collaborative and constructive workplace culture
Full Job Description
JOB DESCRIPTION:

The Opportunity

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in Pleasanton, CA. This team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

What You'll Work On
  • Develops worldwide strategies for regulatory approval of new and modified products.
  • Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
  • Represents Regulatory Affairs on cross-functional product development and manufacturing support teams. Guides teams to provide content for submissions and participates in design reviews as needed.
  • Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
  • Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
  • Reviews, edits, and approves Advertising and Promotional materials.
  • Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies, ensuring that communications are relevant, specific and convey all necessary detail.
  • Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems. Ensures that details of any new or modified regulations are distributed to appropriate personnel.
  • Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
  • Interfaces directly with regulatory agencies as needed.
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
  • Communicates with and maintains productive, constructive relationships with external customers as required - regulatory authorities, Notified Bodies, in-country affiliates and/or distributors.
  • Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with US 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.
  • Performs other related duties and responsibilities, on occasion, as assigned.


Required Qualifications
  • Bachelor's Degree in a related field OR an equivalent combination of education and work experience
  • 3-4 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Organize and track complex information.
  • Exercise good and ethical judgment within policy and regulations
  • Use in-depth knowledge of business functions and cross group dependencies/ relationships.
  • Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.


Preferred Qualifications
  • Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus
  • Experience with either 510(k) applications, PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions.
  • Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
  • Experience with word processing, spreadsheet and presentation graphic software packages is required.
  • 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.
  • Ability to identify, solve problems, and work independently with little oversight.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.


Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

The base pay for this position is
$90,000.00 - $180,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Regulatory Operations

DIVISION:
HF Heart Failure

LOCATION:
United States > Pleasanton : 6101 Stoneridge Dr

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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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