Manager, Regulatory Compliance

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 115000 colleagues serve people in more than 160 countries.

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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 organizations 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 Youll Work On

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Ensure ongoing compliance with FDA regulations (21 CFR Parts) 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

• Associates 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

• Bachelors 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:

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.

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The base pay for this position is

$99300.00 $198700.00

In specific locations the pay range may vary from the range posted.

Operations Quality

NM Neuromodulation

United States > Texas > Plano : 6901 Preston Road

Standard

Not specified

Not Applicable

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: EEO is the Law link - Espanol: Experience:

Manager