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Regulatory Documentation Specialist (Medical Device)
Regulatory Affairs
Duluth, GA, US
Pay Rate Low: 58 | Pay Rate High: 72
Pay Rate Low: 58 | Pay Rate High: 72
- Added - 21/03/2025
Join our amazing team! We want to help you continue to succeed and grow in the life sciences industry!
Our Regulatory Documentation Specialist position is a great opportunity to work with a leading Pharmaceutical and Medical Device company!
This is your chance to work closely with a company dedicated to enhancing quality of life by helping people see better.
Pay: $58-$72/hr (Depending on experience)
Schedule: 1st shift M-F
Type of Job: Contract (6 months; possible extension)
Location: (Onsite- Duluth)
At this time, Astrix cannot transfer nor sponsor a work Visa for this position.
Relocation assistance is not available for this position.
Benefits Offered:
Regulatory Documentation Specialist Daily Tasks: What you will do:
Regulatory Documentation Specialist Qualifications/Requirements: What we are looking for:
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
#LI-DNP
Our Regulatory Documentation Specialist position is a great opportunity to work with a leading Pharmaceutical and Medical Device company!
This is your chance to work closely with a company dedicated to enhancing quality of life by helping people see better.
Pay: $58-$72/hr (Depending on experience)
Schedule: 1st shift M-F
Type of Job: Contract (6 months; possible extension)
Location: (Onsite- Duluth)
At this time, Astrix cannot transfer nor sponsor a work Visa for this position.
Relocation assistance is not available for this position.
Benefits Offered:
- Medical/dental coverage!
- Weekly pay!
- 401k and PTO after 6 months!
Regulatory Documentation Specialist Daily Tasks: What you will do:
- Review, revise, and update clinical documents including literature reports, clinical research protocols, etc. for Medical Device Regulation (MDR) remediation and Postproduction Risk Reviews (PPRRs)
- Support regulatory submissions, ensure compliance with global regulatory requirements, and develop and improve SOPs relating to clinical regulatory documentation.
- Responsible for clinical data appraisals, development and maintenance of Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF), and act as clinical contact for assigned projects and Life Cycle Management.
- Monitor evolving EU MDR, FDA, and ISO 14155 regulations to ensure compliance with clinical evaluation processes.
Regulatory Documentation Specialist Qualifications/Requirements: What we are looking for:
- Experience in writing and reviewing clinical evaluation reports (CERs), literature reviews, and clinical risk assessments.
- Proficiency in European Medical Device Regulations (MDR)
- M.S. or Ph.D. in Biomedical Engineering, Life Sciences, Vision sciences, or related.
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
#LI-DNP
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Regulatory Documentation Specialist (Medical Device)