Regulatory Specialist II

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!