Principal Compliance Audit Specialist
Alajuela Coyol, CR
hace 2 días
source : DirectEmployers Association

Principal Compliance Audit Specialist Location : Jacksonville 6703 Southpoint, Florida, United States Requisition # : 20000B89 Post Date : Jul 21, 2020 Careers That Change Lives In this exciting role as a PrincipalCompliance Audit Specialist , youwill have primary focus responsibility to implement the RTG Internal Auditschedule.

The Restorative Therapies Group developslife-restoring therapies and healthcare solutions that span the care continuum;integrating technologies and applying clinical and economic evidence toincrease patient access, improve efficiency of procedures and deliversuccessful patient outcomes.

A Day in the Life Responsibilitiesmay include the following and other duties may be assigned. + Coordinates and / orcompletes internal / external risk assessments and / or audits in accordancewith regulatory standards, which may include US and / or internationalregulatory agencies / authorities.

  • Manages and overseesinternal audit activities, which may include conducting and / or overseeingaudits, investigations, and / or interviews;
  • and preparing correspondingreports and documents. + Interprets andimplements applicable regulations as they apply to products, processes,practices and procedures.

  • May counselstakeholders about these requirements as necessary. + Ensures compliancewith internal and external regulatory agencies, which may includeinvestigating and resolving compliance violations, questions, or concerns.
  • Analyzes auditdata and presents findings to management and / or regulatory bodies insupport of Corrective Action Plans, which may include coaching businesspartners on compliance gaps, data, and / or resulting corrective actions.
  • Develops andimplements programs, communications, and / or training designed to increaseemployee awareness and knowledge of compliance policies and / or processes.
  • Travelrequirements : 35% Must Have : Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume.
  • Bachelor's degree required (Science or Engineering degree preferred) with a minimum of 7years Quality System Auditing experience OR advanced degree with a minimum of 5years of relevant experience Nice to Have : (Preferred Qualifications) + Experience in Quality / Compliance and / or Audit with medical device requirements (e.
  • g. MDSAP, EU MDR, ISO 13485) + Experience auditing Quality Systems to global requirements + Quality System Lead Auditor certified + Specialized expertise (Sterilization, microbiology, medical device software, combination products, active medical devices, EPRC, radiation emitting devices, robotics) + Prior FDA or NB auditor experience About Medtronic Together, we can change healthcare worldwide.

    At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

    We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

    We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

    Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles : While performing the duties of this job, the employee is regularly required to be independently mobile.

    The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

    ADA-United States of America) It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

    In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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