Sr Compliance/Audit Spec
8200 Coral Sea Street Northeast Saint Paul, MN 55112 US
Job Description
Top 3 things the manager is looking for in a candidates experience:
- Audit Experience with ISO 13485:2016
- Ability to work in a team setting and quick learner
- Organization
Top 3 Tasks or Responsibilities in scope for this role:
- Audit Coordination
- Audit Support and preparation of documentation for audit
- Audit communication to Leadership
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.
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