Abbott

Regulatory Affairs Manager - Heart Failure (on-site)

Abbott • $114K — $228K *
Pleasanton, CA 94566In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a technical discipline or equivalent experience
  • Minimum 6 years of regulatory experience
  • Experience with 510(k) applications, IDEs, PMA, or comparable regulatory pathways
  • Experienced in working within a matrixed, diverse environment
  • Strong communication skills with effective cross-level interactions
  • Ability to manage complex projects and deadlines
  • Ability to anticipate and navigate changing regulatory landscapes

Responsibilities

  • Anticipate and address regulatory obstacles and emerging issues
  • Lead regulatory submissions across functional groups
  • Compile, prepare, and submit regulatory documents to authorities worldwide
  • Communicate regulatory plans effectively to senior leadership
  • Define and implement regulatory strategies and risk assessments
  • Track complex regulatory information and progress
  • Provide technical leadership and guidance to teams

Benefits

  • Comprehensive health and wellness benefits
  • Support for work-life balance and personal well-being
  • Opportunities for professional development and certification
  • Participation in cross-functional teams
  • Engagement in a collaborative and supportive work culture
Full Job Description
JOB DESCRIPTION:

The Opportunity

We are seeking a Regulatory Affairs Manager to join Abbott's Heart Failure Division on-site in Pleasanton, CA.

As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

What You'll Work On

Regulatory Knowledge/Skills:
  • Anticipate regulatory obstacles and emerging issues.
  • Lead functional groups to complete a regulatory submission.
  • Regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Regulatory agency structure, processes and key personnel
  • Principles and requirements of applicable product laws
  • Principles and requirements of promotion, advertising and labeling
  • Interpret and apply regulatory requirements. Compile, prepare, review and submit regulatory submissions to authorities.
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process

Communication:
  • Communicate effectively verbally and in writing.
  • Write and edit technical documents.
  • Communicate and work with people from various disciplines and cultures.
  • Negotiate internally and externally with regulatory agencies.
  • Plan and conduct meetings; Work with cross-functional teams.
  • Clearly explain and articulate Regulatory plans to Senior leaders.

Cognitive Skills:
  • Define regulatory strategy
  • Perform risk assessment or analysis.
  • Juggle multiple and competing priorities.
  • Think analytically with good problem-solving skills.
  • Organize and track complex information.
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Has broad knowledge of various technical alternatives and their potential impact on the business.
  • 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 solve regulatory issues.
  • Lead functional groups in the development of relevant data to complete a regulatory submission.
  • Influencing others to a win/win resolution, appreciating all perspectives.

Leadership:
  • Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
  • Provides leadership by communicating and providing guidance towards achieving business objectives.
  • Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
  • May lead a cross-functional or cross-divisional project team.
  • Provides technical leadership to business units.
  • Exercises judgment independently.


Required Qualifications
  • Bachelor's Degree in a technical discipline or an equivalent combination of education and experience.
  • Minimum 6 years Regulatory experience
  • Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
  • 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 work independently with no oversight.
  • Ability to identify and solve problems in a strategic manner.
  • Ability to manage complex projects.
  • Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.


Preferred Qualifications
  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
  • Advanced degree
  • 8 years' Regulatory experience
  • Experience working in a broader enterprise/cross-division business unit model.
  • Demonstrated experience at a supervisory/managerial level.
  • Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
  • Experience with medical device software requirements and software regulations.
  • Ability to identify risk areas and escalate issues as appropriate.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).


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

The base pay for this position is
$114,000.00 - $228,000.00
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, 10 % 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.

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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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