BS/BE Degree Required
LOCAL TO THE AREA
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
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 post market surveillance studies, and other programs designed to maintain regulatory compliance. Ensures all activities are conducted within the Quality System.
Duties: 1.Ensures compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, Medical Device Directive, ISO 13485, etc).
2.Assists with preparation and submission of domestic and international device approvals, including 510(k)s, IDEs, PMAs, Shonins, CE Marking Design Dossiers, Import and Export Requests, Product Licensing Requests and other requests.
3.Assists in ensuring Premarket Notification files are assembled correctly and in a timely manner. Assists in the development of internal equivalence memoranda for catalog products not requiring FDA review.
4.Assists in the development of Technical Files in accordance with EU MDD requirements for all Class I, IIa, and IIb medical devices. Assists in the assembly of design dossiers for devices identified as Class III under the EU MDD by obtaining and assembling information received from Marketing, R&D, Manufacturing, QE, and other functional groups.
5. Assists in the development and assembly of Shonin files in accordance with RPAL by obtaining and assembling information received from marketing, R&D, Manufacturing, QE, and other functional groups.
6. Attends necessary meetings to obtain timely information for regulatory approval submissions. Works with management to create regulatory strategies and to define the appropriate testing for the proposed device approval requirements. Participates in risk management activities. Assists with and maintains reviews of labeling, change control, and documentation in compliance with domestic and international regulatory requirements.
7. Assists with and oversees maintenance of company’s Medical Device Listing and Device Establishment registration forms. 8. Assists with and coordinates communications with international regulatory contacts and/or distributors to ensure continued regulatory compliance and review of change notifications for consideration of geographic registration requirements.
9. Assists in the development and/or update of policies and procedures to ensure continued compliance with changing domestic and international regulatory requirements. Distributes updates and notices of applicable consensus standards for design and development of devices.
10. Manages, updates, and organizes the regulatory files / archives in the RA file room.
About Engineering Technical Group:
Staffing firm with a focus primarily on Engineering, IT, Aerospace/DOD, oil/gas, medical device, and Manufacturing type of roles.