Compliance Manager at Abbott

Sylmar, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Expertise in setting strategy for internal, clinical, and external audits (Regulatory Agencies, Corporate, Certification bodies, and major clients) to ensure sites are audit ready
Ability to manage a team of auditors across sites and act as a change leader for major global improvement activities in quality systems, audit readiness, and compliance
Experience representing the division in Corporate advocacy forums and external Regulatory Intelligence Forums (e.g., Notified Body Audit Coordination Committee (NBACC), Clinical Audit Forums, Compliance Council)
Knowledge to assess and share compliance health of the division with management and participate in compliance improvement strategies
Capability to head the Compliance Lifecycle Program or similar, establish effectiveness criteria, and advise Executive Management on compliance and audit readiness
Global leadership experience in Cardiac Rhythm Technologies or similar regulated healthcare field

Responsibilities

Manage a team of audit readiness SMEs responsible for auditing/assessing divisional sites, Clinical sites, Commercial Affiliate sites, and Third Party Manufacturers and Suppliers to ensure compliance with Abbott policies, worldwide regulations, and industry standards
Develop department strategy for auditing regulated activities, including proactive strategic planning and resource allocation aligned to quality, regulatory requirements, and business needs
Act as main external regulatory body interface for US sites and direct/manage internal and external inspections/audit strategies across US sites
Serve as Subject Matter Expert for Audit in Inspections and Internal/External Audits
Direct audit management, staffing, logistics, and allocate roles and responsibilities prior, during, and post audit; review and approve audits performed by direct reports and auditing team
Act as Division owner of the Quality Audit reporting IT Systems and Process Owner delegate for Management Responsibilities

Skills

Audit Management

Regulatory Compliance

Quality Systems

Internal Audits

External Audits

Team Management

Change Leadership

Regulatory Intelligence

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees