What are the responsibilities and job description for the Regulatory Compliance Specialist position at Primary Talent Partners?
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 30th (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:
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
#PTPJobs
Pay: $70.00/hr - $90.00/hr based on academia and experience.
Contract: 40 Hrs through April 30th (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.
- 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.
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
#PTPJobs
Salary : $70 - $90
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