Regulatory Affairs Specialist

Experis (Austria)

Eagan (MN)

On-site

USD 25,000 - 30,000

Full time

5 days ago
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Benefits offered by this job

Medical plan
Dental plan
Vision plan
HSA
Health FSA
Dependent Care FSA
Life Insurance
Short/Long Term Disability
Travel Insurance
401(k) with match
Weekly pay

Job summary

ManpowerGroup's client in the healthcare sector is seeking a Regulatory Affairs Specialist to join the Regulatory Affairs team in Eagan, Minnesota. This 100% onsite role supports division-level regulatory operations, global product registrations, and labeling changes for medical devices and some drug products.

The ideal candidate will have a Bachelor's degree and at least 1 year of regulatory affairs experience in medical devices, with experience in international registrations and strong

Qualifications

  • Bachelor's degree or higher in biology, chemistry, pharmacology, biochemistry, or related field.
  • Minimum 1 year regulatory affairs experience in the medical device industry.
  • Experience with international registrations and regulatory documentation.

Responsibilities

  • Contribute to regulatory affairs efforts that support global product registrations and labeling changes for medical devices and some drug products.
  • Work with the international regulatory affairs group to help ensure products are registered globally in alignment with the spinoff strategy.
  • Create, maintain, and update RegDesk tracking records for the rebranding project.
  • Support regulatory documentation and compliance-related tasks as assigned.
  • Collaborate with internal stakeholders to evaluate information accurately and help ensure regulatory alignment.

Skills

Regulatory affairs
Medical devices
International registrations
MS Office
Spanish

Education

Bachelor's degree

Tools

RegDesk

Job description

Our client, a global healthcare organization is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs team supporting division-level regulatory operations. The ideal candidate will have strong attention to detail, the ability to think critically about regulatory requirements, and the discipline to manage deadlines consistently, which will align successfully in the organization.Job Title: Regulatory Affairs Specialist Location: Eagan, Minnesota (100% onsite) Pay Range: $18 to $22 p/h on w-2 Duration: 12 month contract

What's the Job?
  • Contribute to regulatory affairs efforts that support global product registrations and labeling changes for medical devices and some drug products.
  • Work with the international regulatory affairs group to help ensure products are registered globally in alignment with the spinoff strategy.
  • Create, maintain, and update RegDesk tracking records for the rebranding project.
  • Support regulatory documentation and compliance-related tasks as assigned.
  • Collaborate with internal stakeholders to evaluate information accurately and help ensure regulatory alignment.
What's Needed?
  • Bachelor's Degree or higher from an accredited university in a technical field such as Biology, Chemistry, Pharmacology, Biochemistry, or similar.
  • Minimum 1 year of regulatory affairs experience in the medical device industry.
  • Experience supporting international registrations.
  • Proficiency with Microsoft Office applications, including Excel and Word.
  • Spanish language proficiency preferred.
What's in it for me?
  • Opportunity to make a meaningful impact on country registrations and labeling changes tied to a major rebranding effort.
  • Experience working within a regulatory affairs team at the division level and partnering with international regulatory stakeholders.
  • A role that strengthens compliance document creation, product assessment, and regulatory evaluation skills.
  • Clear focus on attention to detail, critical thinking, and time management in a deadline-driven environment.
  • Engagement with LATAM team scheduling needs through flexibility in working hours.
Upon Completion Of Waiting Period Consultants Are Eligible For
  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account
  • Health Flexible Spending Account
  • Dependent Care Flexible Spending Account
  • Supplemental Life Insurance
  • Short Term and Long Term Disability Insurance
  • Business Travel Insurance
  • 401(k), Plus Match
  • Weekly Pay
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.
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