Abbott

Manager, Regulatory Compliance

Abbott • $99K — $198K *
Plano, TX 75025In-Person
Healthcare
5 - 7 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Associate's degree required; Bachelor's preferred
  • Minimum of 7 years relevant experience in regulatory compliance
  • Strong understanding of regulatory requirements and quality management system standards
  • 2-3 years of people management experience preferred
  • Excellent communication skills for interactions with regulators, auditors, and leadership
  • Project and program management skills with high attention to detail

Responsibilities

  • Ensure compliance with corporate and regulatory policies
  • Monitor global regulatory requirements and implement changes
  • Establish regulatory intelligence processes to assess impacts
  • Lead implementation of regulatory changes across the organization
  • Support internal and external audits, including inspections
  • Manage product recalls and safety notices
  • Track compliance metrics and report to leadership

Benefits

  • Health and wellness benefits for employees and their families
  • Diverse career opportunities within the company
  • Support for building a fulfilling future
Full Job Description
JOB DESCRIPTION:

Job Title

Manager, Regulatory Compliance

The Opportunity

This position works on site out of our Plano, TX site supporting the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

The Regulatory Compliance Manager is responsible for ensuring the organization's medical devices comply with applicable global regulatory requirements and industry standards throughout the product lifecycle. This role oversees compliance programs, recalls/field actions, drives regulatory intelligence, drives implementation of regulatory and standards changes across the organization to maintain quality system and product compliance. Regulatory Compliance Manager also supports the quality system by taking action to align activities with Corporate Compliance objectives,

What You'll Work On
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Ensure ongoing compliance with FDA regulations (21 CFR Parts 803, 806, 820), EU MDR/IVDR requirements, and applicable global regulations.
  • Monitor and assess global regulatory requirements and product standards (e.g., FDA, EU MDR/IVDR, ISO 13485, ISO 14971).
  • Establish processes for regulatory intelligence gathering and impact analysis.
  • Evaluate the impact of regulatory and standard updates on existing products, processes, and quality systems.
  • Lead implementation of regulatory and standards changes, ensuring alignment with internal processes.
  • Communicate changes to stakeholders and provide guidance on compliance requirements. Translate regulatory requirements into actionable project plans.
  • Monitor project timelines, risks, and deliverables to ensure compliance and timely execution.
  • Support internal and external audits, including regulatory inspections.
  • Develop and maintain policies, SOPs, and work instructions related to recalls and regulatory updates.
  • Lead and manage product recalls, field corrections, and safety notices in compliance with FDA (21 CFR Part 806), EU MDR, and other global regulations.
  • Perform health hazard evaluations (HHEs) and risk assessments to support escalation decisions.
  • Interface with regulatory authorities and notified bodies as needed. Ensure timely reporting to regulatory authorities (e.g., FDA, EMA, Health Canada, MHRA).
  • Monitor recall effectiveness and conduct recall effectiveness checks.
  • Track and report compliance metrics and KPIs to leadership.


Required Qualifications
  • Associate's degree
  • Minimum of 7 years of relevant experience
  • Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups
  • Facilitates others' participation in the continuous improvement program
  • Investigates and solves problems that impact work processes and personnel within or across units or departments
  • Develops and communicates a vision for the organizational unit assigned


Preferred Qualifications
  • Bachelor's degree preferred.
  • Minimum of 2- 3 years of people management
  • Strong understanding of regulatory requirements and QMS standards
  • Confidently communicate with regulators, auditors, and leadership
  • Project and program management skills
  • Excellent communication and stakeholder management
  • High attention to detail and organizational skills


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
$99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
NM Neuromodulation

LOCATION:
United States > Texas > Plano : 6901 Preston Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time 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 Manager, Regulatory Compliance jobs:

NationwidePlano, TX