The Principal Specialist, Regulatory Affairs will be responsible for the support of new product development and maintenance of business projects.
Specific activities include but are not limited to:
Under direction, support new product development/modifications projects to establish and integrate regulatory submissions strategy into project activities.
Under direction, prepare submissions (i.e. 510K, CE marking applications, technical documentation, etc.) to obtain domestic filings, European regulatory approvals, and maintain existing regulatory approvals through Letter to File, renewals, change notifications, etc.
In collaboration with International Regulatory Affairs, determine applicable registration requirements and assist with STED Preparation for medical devices in countries in which products are to be registered.
Interpret and/or evaluate proposed registration requirements for medical device and advice on impact of such regulations to the company.
Review device labeling and advertising materials for compliance with regulations and product filings.
Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.
Evaluate, develop and implement business process improvements.
Bachelor’s degree required
4+ years Regulatory Affairs experience or equivalent required
Majority of Regulatory Affairs experience in Medical Device industry preferred