Senior Regulatory Affairs Manager
Location: Richmond, VA
Name: Miranda Eilers
Aerotek is currently hiring or a direct placement, Regulatory Affairs position.
Manage eFlow operations including production and supply chain
Responsible for regulatory affairs pertaining to the eFlow medical device component of combination products from clinical to commercial
Primary point of contact for eFlow pharmaceutical partners
Regulatory support for drug/device combination product partner projects representing the eFlow device
Direct production activities including planning and resources for clinical supplies and commercial products
Liaison between the client and pharmaceutical partners on regulatory strategy, filings, clinical trial supplies, and device change management process for North American territory
Communicate with partners on complaints, postmarket feedback, and other quality issues pertinent to the eFlow device
Direct project management including product development, regulatory documentation, design control and change control activities
Manage/supervise Production, Materials Warehouse, and Project Management personnel and activities
* Strong knowledge of regulatory requirements for medical devices and drug/device combination products
* Proficiency with FDA GMP, ISO 13485, and Canadian Medical Device regulations, concepts, procedures
* Computer Proficient in a Windows environment (Word, Excel, PowerPoint, Outlook, etc.). SAP knowledge and experience preferred.
* Minimum 8 years' experience in combination of Regulatory Affairs and Operations in a Medical Device Manufacturing Environment
* Bachelor's Degree in Business, Engineering or related technical field, or a comparable combination of education and experience
* US RAC or comparable regulatory certification preferred
Strong Operations experience in Production & Supply Chain
Medical device or drug experience.
Project Management experience.
Our people are everything. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With over 230 non-franchised offices, Aerotek serves 17,000 clients and 300,000 contract employees every year. To learn more, visit aerotek.com.