Principal Compliance & Audit Specialist

Medtronic   •  

Northridge, CA

Industry: Manufacturing

  •  

8 - 10 years

Posted 38 days ago

This job is no longer available.

Careers That Change Lives


In this exciting role as a Principal Compliance/Audit Specialist you will play a lead role in driving compliance for a growing medical device business unit and have responsibility for managing and executing the Internal Audit Program.

DIABETES

Transforming diabetes care together, for greater freedom and better health.

Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
  • Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.

  • Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.

  • May counsel stakeholders about these requirements as necessary.

  • Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.

  • Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.

  • Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

  • Supports external audits and inspections by coordinating preparation activities, managing logistics during execution and tracking any required follow-up tasks.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelors Degree with 7+ years of work experience in Quality and/or Compliance/Audit OR Masters Degree with 5+ years of work experience in Quality and/or Compliance/Audit.

  • Current Lead Auditor Certification from a recognized professional organization or an accrediting organization

  • Experience auditing to US FDA 21CFR820 and Part 11

  • Experience auditing to Europe MDD, AIMD

  • Knowledge of EUMDR Requirements

  • Experience auditing to ISO13485

Nice to Have (Preferred Qualifications)

  • Experience auditing to and/or knowledge of the following:

    • Canadian Medical Device Regulations

    • China Food and Drug Administration (CFDA)

    • Therapeutic Goods Administration (TGA)

    • Ministry of Health, Labor and Welfare (MHLW) Ministerial Ordinance No 169


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)

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