Job Title: Compliance/Audit Specialist - Exempt

Job Description

We are seeking a Compliance/Audit Specialist with extensive experience in Quality Management System Requirements, including 21CFR820, ISO13485, and ISO14971. This role involves performing internal and external audits and ensuring compliance with regulatory standards. The candidate will work onsite in Rice Creek, Fridley, MN, for 3 days a week and remotely for 2 days a week.

Responsibilities

• Coordinate and prepare internal and external audits and compliance in accordance with regulatory standards, including FDA and equivalents outside the US.
• Interpret government regulations as they apply to products, processes, practices, and procedures.
• Implement policies and procedures to ensure compliance with appropriate statutes and regulations.
• Ensure regulatory reporting requirements are met.
• Investigate and resolve compliance problems, questions, or complaints from other units, customers, and government regulatory agencies.
• 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 to increase employee awareness and knowledge of compliance policies.
• Deliver and manage projects from design to implementation while adhering to policies.

Essential Skills

• Extensive experience with 21CFR820, ISO13485, and ISO14971.
• Strong communication skills.
• Ability to work independently.
• Minimum of 2 years of relevant experience with a University Degree or advanced degree with no experience.
• Practical knowledge and demonstrated competence within job area.

Additional Skills & Qualifications

• Internal audit experience preferred but not required.
• Audit experience preferred but not required.
• 0-3 years of medical/clinical experience or exposure.
• Auditor certification.

Work Environment

The candidate will work onsite in Rice Creek, Fridley, MN, for 3 days a week and remotely for 2 days a week. The initial contract is for 40 hours per week through April 30th, with a high likelihood of extension through July 2025. The role involves working independently with general supervision on larger, moderately complex projects or assignments.

Pay and Benefits

The pay range for this position is $60.00 - $80.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Fridley,MN.

Application Deadline

This position is anticipated to close on Feb 28, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $60 - $80