Job Duties : Ensure compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements.Prepare required documentation (510(k)s, technical files, dossiers) for domestic and foreign submissions and registrations. Attend design review meetings regarding design controls. Interacts with other departments to assist in determining the Regulatory pathways required for products that are in the development process.,Research medical literature, regulatory documents and related information for inclusion into clinical articles and regulatory submissions and for evaluating manuscripts for accuracy, completeness, and adherence to regulatory requirements.,Maintain department change control and compliance systems (ECR/ECN, CAR, etc.),Maintain systems for labeling, promotional material, change control and the documentation for these systems as required by domestic and foreign governments.,Complete and maintain company’s Medical Device Listing and Device Establishment registration forms.,Handle regulatory related requests/questions from internal and external sources.,Represent the company in issues related to legal and review agencies in support of regulatory requirements.,Recognize and initiate projects related to long term product registrations or department growth / improvement.,Maintain Regulatory department involvement and maintenance of information in company software and product databases.
Candidate supports the development and administration of regulatory activities and submissions in compliance with all applicable domestic and international regulations, guidelines, and other requirements. Assists in the development of submissions for domestic and international device approval, provides support for clinical and postmarket surveillance studies, and other programs designed to maintain regulatory compliance. Ensures all activities are conducted within the Quality System.
Qualifications: -BS or BA degree required. (Engineering or life sciences preferred). -4+ years experience in Regulatory Affairs, medical device industry preferred or equivalent college coursework in Regulatory Affairs -Working knowledge of FDA, FDA QSRs, ISO 13485, Canadian Medical Device Regulations, and the European MDD required -Demonstrated ability to manage projects -Excellent verbal and written communication skills -Excellent analytical and problem solving skills -Excellent interpersonal skills -Word processing skills including Microsoft Word, Excel
