Regulatory Specialist II
Job Summary
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
Benefits
- 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
Pay & Schedule
Pay Range: $42.22 BR - $57.49
Qualifications
Upon completion of a waiting period, consultants are eligible for the following benefits:
- 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
Schedule
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!