Director, Regulatory Compliance

Company: Abbott Laboratories
Location: Saint Paul
Posted on: November 22, 2021

Job Description:

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 109,000 colleagues serve people in more than 160 countries.Structural Heart Business Mission:-- why we existOur business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. Position Summary The job purpose and scope of the Director, Regulatory Compliance position for Structural Heart is to Lead a management team and technical staff within business unit for SH division Quality organization responsible for ensuring product safety, reliability, and quality. Description of Job ScopeThis position is responsible for:

• Lead the compliance function division wide.
• Ensure that processes and staffing are appropriately developed and implemented to maintain the quality system.
• Set strategic vision/goals in alignment with site organization and division
• Ensure compliance within organization to all applicable internal requirements and external regulations and establishes/maintains quality system.--
• Interprets and recommends modifications to company wide policies and practices.
• This role helps to maintain a constructive regulatory compliance position for the site through the early identification, correction and prevention of compliance issues. Qualifications
  • ---BA/BS degree in related field, MBA desirable.
  • ---10 plus years of related work experience
  • ---Experience in Medical Device or Structural Heart industry is preferred Key attributes considered necessary for success
    • Ability to work collaboratively, internally and externally.
    • Ability to manage/prioritize multiple projects and adapt to a changing, fast-paced environment.
    • Ability to lead a team and work in a group environment.
    • Must be highly analytical; possess strong interpersonal skills including influencing, negotiation and teamwork skills.
    • Must possess excellent oral and written communication skills.
    • Ability to think strategically, develop frameworks and platforms that ensure optimal and unfettered access to business tools, assets and capabilities.
    • Demonstrated management skill.
    • Proven ability to employ various flexible communications vehicles to drive messaging across a broad, varied and dispersed commercial organizations.

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