Abbott

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

Abbott • $85K — $156K *
Pleasanton, CA 94566In-Person
Healthcare
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent experience
  • 5 years of relevant work experience
  • Bachelor's in biology, chemistry, microbiology, or related technical field preferred
  • 5+ years in the Medical Device industry preferred
  • 1-2 years of regulatory experience preferred
  • Experience with 510(k), PMA, or international submissions preferred
  • RAPS Certification preferred

Responsibilities

  • Verify regulatory requirements with supervisory staff regarding product development and submissions
  • Provide technical leadership and strategic input to business units on complex regulatory issues
  • Develop solutions to anticipated regulatory obstacles throughout the product lifecycle
  • Analyze regulatory outcomes against product concepts to refine strategies
  • Implement Division Regulatory Strategy in product-related activities
  • Prepare clear and concise written information for various audiences
  • Follow GMP guidelines and procedures in all regulatory tasks

Benefits

  • Comprehensive health and wellness benefits
  • Support for a balanced lifestyle for employees and their families
  • Flexible work arrangements
  • Opportunities for professional development and continuing education
  • Participate in a supportive and collaborative team environment
Full Job Description
JOB DESCRIPTION:

The Opportunity

We are recruiting for a Regulatory Affairs Specialist II to join our team on-site in Pleasanton, CA. This new team member will apply regulatory understanding to support of product and teams as well as prepare US regulatory submissions and/or registration documents. Additionally, will handle regulatory activities involved in documentation, labeling, and apply regulatory and technical knowledge to a focused area of work assignments. This Specialist understands, implements, and maintains the quality policy and ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

What You'll Work On

  • Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance and project plans.
  • Provide technical leadership and strategic input on complex issues and to business units.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
  • Develop global regulatory strategies for product development and planning throughout the product lifecycle.
  • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
  • Implements Division Regulatory Strategy in specific product related activities.
  • Basic understanding of medical device regulations.
  • Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
  • Analyzes the input of product changes to current product submissions.
  • Lead functional groups in the development of relevant data to complete a regulatory submission.
  • Follows through on submission related activities to secure product approval.
  • Shares knowledge with others in department and on teams.
  • Establishes and executes against project goals and implements plans.
  • Provides input to establishing group plans and implementation of those plans.
  • Follows GMP guidelines and procedures.
  • Writes Effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions
  • For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies.
  • Signs-off at team level within delegated parameters for change control.
  • Directs own daily activities by utilizing team goals and division regulatory priorities.
  • Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
  • Obtains supervisory regulatory review on submission documents prior to submission to government agencies.


Required Qualifications
  • Bachelor's Degree or an equivalent combination of education and experience
  • 5 years' work experience


Preferred Qualifications
  • Bachelor's degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.
  • 5+ years' experience in Medical Device industry•
  • 1-2 years of regulatory experience
  • Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.
  • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
  • Think analytically with good problem-solving skills.
  • 510(k), PMA, or other international regulatory submission experience.
  • RAPS Certification.


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
$85,600.00 - $156,000.00
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.

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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Abbott

More Healthcare Jobs

Find similar Regulatory Affairs Specialist II - Heart Failure (on-site) jobs:

NationwidePleasanton, CA