Senior Regulatory Specialist Penumbra, Inc.
THIS JOB HAS EXPIRED Job TitleSenior Regulatory Specialist
Job DescriptionResponsible for research, preparation, coordination, filing and maintenance of document package submissions for new products and changes to existing products, in compliance with regulations and procedures required by U.S. and international regulatory bodies. Provides regulatory guidance in product development during design and concept phase and throughout the product lifecycle. Ensures regulatory compliance and optimization of quality system procedures.
Duties? Assist in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, non-US Clinical Trial Submission, 510(k), PMA, PMA Annual Report, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical Files, International Dossiers, and Certificates to Foreign Government.
?Perform the following activities in support of submissions: research, identification of filing regulations, correspondence, scheduling, tracking, trending analysis, translation support, filing preparation and document maintenance for compliance with U.S. and international regulatory requirements.
?Track and ensure that existing worldwide product registrations are maintained and updated as required.
?Communicate with worldwide regulatory authorities to facilitate global registrations.
?Review and approve new and updated drawings, protocols, reports, packaging, advertising/promotional materials and procedures to ensure regulatory compliance.
?Provide interpretation of FDA and international regulations and guidelines as needed to support accomplishment of organizational objectives.
?Partner with cross-functional team members to ensure that regulatory strategies are compliant, aligned with business objectives and are incorporated into the appropriate product development project phases.
? Monitor FDA clearances and approvals of competing products.
?Participate in internal and external audits, including the monitoring and tracking of open non-conformances and observations.
?Analyze existing systems and procedures; recommend improvements; draft or revise Work Instructions and SOPs as needed to support departmental functions and the Quality System.
?Ensure regulatory compliance and optimization of quality system procedures relating to product development, commercialization, advertising/promotion and risk management.
?Perform other duties required by the Quality System as assigned.
QualificationsRequires Bachelor?s degree in a scientific or related discipline; Master?s degree preferred. Five to seven years relevant regulatory experience in the medical device or a related industry, or an equivalent combination of education and experience. Working knowledge of quality systems and QSR, Design Control, Medical Device Directive, ISO 13485, biocompatibility requirements and regulations, procedures and practices required by regulatory bodies for medical device industry activities. Demonstrated success creating, submitting and making changes to domestic and international regulatory submissions, applying appropriate technical standards, principles, theories, concepts, and techniques. Strong PC and Microsoft Office skills (Word, Excel, Outlook).
||Alameda, CA |
THIS JOB HAS EXPIRED