1+ months

Staff Regulatory Compliance Specialist

Abbott
Plymouth, MN 55447
  • Jobs Rated
    25th

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 103,000 colleagues serve people in more than 160 countries.

We are seeking an experienced, high caliber Staff Regulatory Compliance Specialist to assure products, processes, and quality records conform to quality standards and establish compliance with the quality system.  This role will include responsibilities for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.

Impact this role will have on Abbott:

  • Provides project direction, coaching, teaching, leadership, and mentoring for team personnel.
  • Leads multifunctional teams in completing program directed or continuous improvement activities.
  • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Support the Electrophysiology (EP) business in preparation for and execution of external audits and inspections at all applicable sites.
  • Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
  • Conduct quality system-related training periodically for appropriate audiences.
  • Drive execution of quality data analysis, trending, and reporting. Proficiency with reporting and publishing periodic metrics.
  • Support successful CAPA execution.
  • Work with Abbott EP sites to support regulatory submissions and renewals by compiling necessary quality information in collaboration with international partners.
  • Proficiently lead meetings and communications for quality system information, concerns, and updates.
  • Ensure database and record storage maintenance and integrity for quality system processes.
  • Identify and execute continual improvement opportunities within quality system processes.
  • Support all Abbott initiatives as identified by senior management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Perform other related duties and responsibilities, on occasion, as assigned.

    Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

    • Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred).
    • Minimum 8 years technical experience.
    • Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.
    • Detailed knowledge of FDA, GMP, and ISO 13485.
    • Solid communication and interpersonal skills.
    • Demonstrated supervisory experience.
    • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
    • Advanced computer skills, including statistical/data analysis and report writing skills.
    • Prior medical device experience.
    • Ability to work in a highly matrixed and geographically diverse business environment.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Ability to leverage and/or engage others to accomplish projects.
    • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. 
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Multitasks, prioritizes and meets deadlines in timely manner.
    • Strong organizational and follow-up skills, as well as attention to detail.
    • Ability to travel approximately 5%.
    • Ability to maintain regular and predictable attendance.

      Preferred qualifications and education:

      • Prior medical device experience preferred.
      • ASQ CQT, CQE, CQA certification preferred.
      • Experience with medical device audits/inspections preferred.
      • Experience working in a broader enterprise/cross-division business unit model preferred.

        ","industry":"Healthcare","title":"Staff Regulatory Compliance SpecialistDivision: EPHF Electrophysiology & Heart Failure
        Travel: Yes, 5 % of the Time
        Medical Surveillance: Not Applicable
        Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Jobs Rated Reports for Compliance Officer

Posted: 2020-08-05 Expires: 2020-10-21

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Staff Regulatory Compliance Specialist

Abbott
Plymouth, MN 55447

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Compliance Officer
25th2018 - Compliance Officer
Overall Rating: 25/220
Median Salary: $67,870

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