Job Description

Our client, a leading organization in the medical device industry, is seeking a Regulatory Affairs / Operations Specialist to join their team. As a Regulatory Affairs / Operations Specialist, you will be part of the Regulatory Affairs department supporting various project teams. The ideal candidate will have strong attention to detail, excellent organizational skills, and the ability to communicate effectively, which will align successfully in the organization.

Job Title: Regulatory Affairs Specialist

Location: Lake Forest, IL

Pay Range: $36.00 -$38.00 per hour

What's the Job?

• Provide regulatory operations support working closely with Global Regulatory Leaders and project teams.
• Plan and organize electronic registration packages for medical device products using the FDA's eSTAR program.
• Prepare technical documentation registration packages in line with notified body requirements and regional regulatory guidelines.
• Collaborate with regional Regulatory Affairs counterparts to ensure compliance with applicable regulations.
• Track and complete assigned registration activities while ensuring accuracy and meeting deadlines.

What's Needed?

• Bachelor's Degree preferred in life sciences or Computer Science related subject.
• 2-4 years of experience in medical device electronic submissions to regulatory bodies.
• Excellent knowledge of publishing tools and electronic submission standards.
• Detail-oriented with the ability to prioritize workload and multitask with minimal supervision.
• Strong interpersonal and communication skills, both oral and written.

What's in it for me?

• Opportunity to work in a dynamic and collaborative environment.
• Gain experience in regulatory affairs within the medical device industry.
• Develop skills in electronic submission processes and regulatory compliance.
• Be part of a team that values innovation and excellence.
• Potential for career growth and advancement within the organization.

Upon completion of waiting period associates are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Supplemental Life Insurance
• Short Term Disability Insurance
• 401(k)

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent. Manpower Inc

Job Tags

Hourly pay, Temporary work,

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