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ManpowerGroup

Regulatory Specialist II

Pay: $42.22–$57.49/hr
Posted: 5 weeks ago
Location: South Portland, ME (Onsite)
Last Updated: 1 week ago
Hours: Full-Time
Expires: 9/29/2026

Career Insights for Regulatory Affairs Specialist

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Based on Maine data

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What they do

A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.

$97,937 / year median in Maine

+2% projected growth

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Job Description

  • Job Title:
  • Regulatory Specialist II
  • Location:
  • South Portland, ME
  • Pay Range:
  • $42.22 BR - $57.49
  • Job Details:
  • + Prepare documentation for EU Technical Files and international product registrations in accordance with IVDR regulations.
+ Provide regulatory support for diagnostic product development and commercial diagnostic products. + Develop regulatory strategies to achieve product clearance/approval in the EU and globally. + Assist regional regulatory teams with submissions, license renewals, and amendments. + Research and communicate scientific and regulatory information to support submission documents.
  • What's Needed?
  • + Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering, or related technical field. + At least 4 years of experience in a Regulatory Affairs role. + Strong knowledge of IVDR and EU regulatory requirements. + Excellent written and verbal communication skills. + Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Visio.
  • 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 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!

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.