d) Regulatory Compliance - EMEA at Abbott

Eschborn, Hesse, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Based in Eschborn, Germany
Experience managing compliance functions in healthcare/medical devices, particularly in EMEA
Knowledge of regulatory requirements including MDD, MDR, and national legislation in EU countries, Middle East, and Africa
Ability to manage relationships with Competent Authorities and Notified Bodies
Experience serving as EC Authorized Representative
Expertise in Field Action processes (e.g., FSCA planning, rollout, and reconciliation)
Skills in recruiting, coaching, and developing organizational talent
Capability to support inspections by Regulatory Agencies and internal audits, including CAPA system management

Responsibilities

Support all business units of CN – CRM, EP, HF, NMD and SH to comply with regulatory requirements of the MDD, MDR, national legislation in EU countries, Middle East and Africa
Successfully manage relationships with Competent Authorities and Notified Bodies
Serve as contact of the EC Authorized Representative for Abbott Medical Cardiovascular & Neuromodulation
Work with the legal manufacturer to ensure Field Action related material and documents are suitable for EMEA, as well as determine plan method and timeline, roll out and reconciliation of FSCA
Manage, maintain and improve Regulatory Compliance activities in EMEA
Monitor compliance with company policies and procedures for the area responsible
Make decisions regarding work processes or operational plans and schedules to achieve compliance objectives for the business units
Recruit, coach and develop organizational talent
Support inspections of the business unit by outside Regulatory Agencies, or internal audits, including any required responses for the role inherent
Lead organization responsible for quality support activities including those activities associated with identification and resolution of key product and process performance issues, often through the CAPA system
Manage the compliance function supporting the Cardiovascular & Neuromodulation business units in EMEA
Ensure processes and staffing are appropriately developed and implemented to maintain the quality system
Participate in establishing strategic vision/goals in alignment with site organization and business units
Ensure compliance within the organization to all applicable internal requirements and external regulations
Establish/maintain the quality system for the role responsible in the area with oversight
Interpret and recommend modifications to companywide policies and practices
Interface with outside regulatory agencies
Identify, correct and prevent compliance issues
Support of the quality system

Skills

Regulatory Compliance

EMEA Regulations

Cardiovascular

Neuromodulation

Compliance Management

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

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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