Location: Colorado Springs CO
Duration: 12 Months
Experience working in international regulatory affairs
Ability to provide strategic and execution-level regulatory affairs support (e.g. draft regulatory filing documents)
Experience reviewing regulatory affairs elements of Clinical Evaluation Reports (CER), Risk Management files, Verification and Validation Reports, labeling
Experience with disposable devices (e.g. guidewires/catheters/sheath introducers) would be preferred as an understanding of materials, biocompatibility, and sterility would be beneficial
Key Deliverables – Key Success Factors:
Regulatory strategy guidance for client teams
Development of regulatory plan and protocols
Development of regulatory submission documents
Facilitate implementation of new Regulations such as EU Medical Device Regulations
Participate in NPD as the Regulatory core team member
Review of documents and project deliverables including but not limited to:
Clinical Evaluation Reports (CER)
Risk Management files
Verification and Validation Reports
Labeling
Regards,
Vikas
Vikasy@apninc.com