Job Description
Job Overview:
JOB DESCRIPTION:
Job Title
Manager, Regulatory Compliance
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
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
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. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews
The base pay for this position is
$99,300.00 – $198,700.00In 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)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
