Regulatory Compliance Specialist

Primary Talent Partners has a 3-6 month contract opening for a Regulatory Compliance Specialist to join a multinational medical device company for a hybrid position operating out of Minneapolis, MN.

Pay: $70.00/hr - $90.00/hr based on academia and experience.
Contract: 40 Hrs through April 30^th (contract may be extended, working on getting the budget approved)  It is highly likely that the contract will go through July 2025.
Type: W-2, cannot support C2C or provide visa sponsorship
Hybrid: Onsite 3 days a week, 2 days are remote.

Responsibilities:

• 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.

Qualifications:

• Bachelor's degree in scientific / engineering discipline.
• Medical Device experience -- extensive experience with 21CFR820, ISO13485 and ISO14971 for Quality Management System Requirements
• 6-10 years of relevant experience
• Ability to work independently
• Strong Communication skills
• Internal Audit experience preferred but not required.
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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