Compliance/Audit Specialist (3-6 month contract // Minneapolis, MN):

This role is hybrid, 3 days on site per week

HM's Top Needs:

1. Extensive experience with 21CFR820, ISO13485 and ISO14971 for Quality Management System Requirements
2. Internal Audit experience preferred, but not required
3. Ability to work independently with strong communication skills
4. Audit experience preferred but not required

Duties:

• Performs the coordination and/or preparation of internal and external audits and compliance in accordance with regulatory standards (includes FDA and its equivalents outside the US as well as other government regulatory agencies / authorities).
• Interprets government regulations as they apply to products, processes, practices and procedures.
• Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met.
• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Analyze audit data and present findings to management, support Corrective Action Plans, and provide coaching to business partners.
• Assist in managing recalls and field actions.
• Develop and implement programs designed to increase employee awareness and knowledge of compliance policies.