Abbott

Senior Regulatory Affairs Specialist - Lingo (on-site)

Abbott • $90K — $180K *
Alameda, CA 94501In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a technical field such as biology or medical technology.
  • Minimum 2 years of regulatory or relevant industry experience.
  • Advanced degree in Engineering or related fields is preferred.
  • Experience with 510k/PMA submissions for Class I/II software devices is a plus.
  • Knowledge of AI/ML technologies in digital health is valuable.
  • Familiarity with FDA Quality System Regulations (QSR) is beneficial.
  • Strong written and verbal communication skills are essential.

Responsibilities

  • Represent Regulatory Affairs in cross-functional teams, providing strategic regulatory input.
  • Assess and communicate the acceptability of medical device submission documentation.
  • Assist with the development and review of standard operating procedures for new products.
  • Evaluate regulatory history related to therapeutic areas to inform approval processes.
  • Prepare and review regulatory submissions for compliance with authorities.
  • Implement regulatory actions for proposed design or labeling changes as needed.
  • Develop procedures for design control in collaboration with stakeholders.

Benefits

  • Comprehensive health and wellness benefits for you and your family.
  • Diverse career growth opportunities within the company.
  • Supportive environment to help build your future.
  • Flexibility to manage work-life balance effectively.
Full Job Description
JOB DESCRIPTION:

Senior Regulatory Affairs Specialist will work on-site out of our Alameda, CA or Milpitas, CA locations in the Diabetes Care Division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred. This role will also be an important resource for the regulatory department to ensure efficient and compliant business processes. This is an exciting opportunity to work in the dynamic and evolving digital health space.

What You'll Work On
  • Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices
  • Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance
  • Assist in SOP development and review in support of "next-gen" product offerings
  • Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval
  • Assist in preparation and review of regulatory submission to authorities
  • Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action
  • Develop and refine design control procedures in collaboration with other stakeholders
  • Utilize technical regulatory skills to propose strategies on complex issues
  • Ensure compliance with product post marketing requirements
  • Review product labeling to ensure compliance with relevant regulatory requirements
  • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Influences middle management on technical or business solutions


Required Qualifications
  • Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
  • Minimum 2 yrs. regulatory experience and/or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function


Preferred Qualifications
  • Advanced degree in Engineering, Sciences, or related discipline
  • Previous experience with 510k / PMA submissions or class I / II exempt software devices
  • Knowledge of insulin dosing products and diabetes management solutions
  • Previous experience with SaMD, AI/ML, and other digital health technologies
  • Familiarity with Predetermined Change Control Plans (PCCPs)
  • Experience with Medical Devices
  • 4-6 years' experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area
  • Ability to work effectively on cross-functional teams
  • Must be able to juggle multiple and competing priorities
  • Strong written, verbal, presentation, and organizational skills
  • Working knowledge of FDA QSR
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Has a sound knowledge of a variety of alternatives and their impact on the business


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:
LNGO Lingo

LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway

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

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