Technical File documentation assessment and support

EU MDR Migration of Technical Documentation Assessment

Project Manager is responsible for leading multiple complex projects and related work streamsResponsible for independently preparing and submitting regulatory submissions for the U.S., including 510(k)s, PMAs, PMA SupplementsCoordinating IDE submissions, and interacting with regulatory agencies regarding submissions. Responsible for preparing original STEDs, EU technical files, design dossiers, and technical file revisions for the Global marketObtains approval of new products and provides regulatory requirements to help ensure efficient use of product resourcesReviews labeling to ensure compliance with regulatory requirementsProvides product information and regulatory guidance and support to project core teams including processing ECOs, providing guidance and review of promotional materials, and communicating regulatory pathways. Serves as a consultant and technical expert on Regulatory Affairs matters. Provides assistance in preparation and submission of global regulatory documents

Preparation of US FDA 510(k) and PMA submissions, if applicable.Advise / support clinical team and project team to plan and prepare clinical data for submissionsSupport international product registrations, approvals and licenses.Provide regulatory oversight and guidance to new product development teams.Support product engineering/manufacturing staff to review, assess and approve product modifications to determine appropriate regulatory requirements.Review and approve customer publications, labels, marketing, advertising and/or promotional materials for compliant and accurate content.Analyze, manage and assist as necessary with post market incident analysis reporting activities.Provide risk management expertise on applicable medical device regulations to business partners.

Initiate and coordinate the Field Action execution process in a timely manner. Ensure compliance and completion of appropriate internal forms according to the internal Standard Operating Procedure. Obtain information from appropriate internal representatives. Consider deliverables for customer notification, product disposition at warehouse and customer sites, Create Customer Notification Letters within the product scope i.e., outcome of Heath Hazard Evaluations and Quality Review Board recommendations, product codes and associated lots/serial numbers. Identify all internal and external communication needed for product recall execution(s). Confirm Regulatory Notified Bodies that require notification. Document objective evidence of product holds, disposition of product and returned stock. Monitor effectiveness of recall activities. Prepare 806 documents for submission to the FDA. Provide guidance and direction to peers, serve as expert in field action and complaint handling process. Preparing updates to FDA for Open Field Actions. Responding to external questions regarding field actions. Serve as internal expert regarding open field actions. Be familiar with laws and standard operating policies that apply to the position, and maintain the highest levels of professionalism, ethics and compliance at all times.

Initiate and coordinate the Field Action execution process in a timely manner.Ensure compliance and completion of appropriate internal forms according to the corporate internal Standard Operating Procedure.Obtain information from appropriate internal representatives.Consider deliverables for customer notification, product disposition at warehouse and customer sites.Create Customer Notification Letters within the product scope i.e., outcome of Health Hazard Evaluations and Quality Review Board recommendations, product codes and associated lots/serial numbers.Identify all internal and external communication needed for product recall execution(s).Confirm Regulatory Notified Bodies that require notification.Document objective evidence of product holds, disposition of product and returned stock.Monitor effectiveness of recall activities.

Management Representative to act as liaison between the company and various Domestic and International Regulatory notified bodiesEnsure the development, manufacture and distribution of medical products in compliance with, U.S. FDA regulations, EU Medical Device Directive, and ROWProvide strategic tactical advice and guidance to senior management and project teams for timely and efficient conduct of development programs.Coordinate and prepare regulatory submissions, including 510(k) premarket notifications, EU MDD Technical Files, and ROW registrations• Interface as needed with the U.S. FDA, Notified Bodies and other national health agencies regarding new products and significant changes to products.Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and appropriate regulations.Ensure applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met by working in cross function departmental teams generating risk analysis, FMEA, FTA and risk management reports.Perform internal and external vendor audits on schedule; present succinct, well-written findings to Executive Management.Review all product labeling, advertising and promotional materials to ensure that information is congruent with the data collected and is in accordance with applicable regulatory requirements. Provide complaint guidance as a subject matter expert and support MDR, Complaint and work with Engineering Investigation team to provide responses to the FDA and Authorized Representative. Reach out to the complaintant to gain custody of the device for complaint investigation. Ensure complaint logs, MDR and remediation activities are tracked and trended for effective communication to the senior management team. Report to the Authorized Representative in identifying regulatory compliance requirements for executions of Global Adverse Reporting.

Responsible for obtaining product approvals from the US FDA. These activities include but are not limited to writing submission documentation for 510(k), Premarket Notifications, Technical Files, Canadian Medical Device License applications and amendments, and providing appropriate follow-up responses and reports.Worked as a project team member, identifying regulatory requirements throughout the product development process.Review new or revised regulatory guidance or standards and implement any changes that are applicable to support regulatory compliance.Utilize project management skills to track and trend completion of nonconformance issues for Management Review.Serve on CAPA teams to resolve nonconformance findings.Internally manage and coordinate closure of nonconformance findings through objective evidence and robust, accurate regulatory responses.Manage and coordinate the rebranding process for review of labeling changes post acquisition. All layers of labeling including the master carton, product carton, instructions for use, work instructions, training documents and marketing literature to ensure compliance to FDA and other international standards in support of CE marking activities.Support software design teams to assure compliance of software changes, risk management activities and regulatory strategies including 510(k) letters to file, 510(k) submissions, regulatory notified body submissions including but not limited to EU and Health Canada and ROW notified bodies.Responsible for pre and postmarket surveillance, MDR reporting and recall management.Review and approve Engineering Change Orders for regulatory compliance.

Preparation of US FDA 510(k) and PMA submissions, if applicable.Develop regulatory strategies for obtaining product approvals from The US FDA, Health Canada, EU MDD and ROW regulatory notified bodies.Communicate with regulatory notified bodies for follow up on product submissions and establishment registrations.Participate in resolution of audit non-conformances and serve on CAPA teams.Manage design review meetings to review and assess changes to the design, manufacturing, labeling, or sterilization of productsManage the creation, maintenance and provide necessary copies of international dossiers, CE certificates, Certificates of Foreign Government and other regulatory documents to International Health Authorities and distributorsManage the submission of applications of state license applications with Board of Pharmacies for medical device systems that include drugs.

Manage 50,000 square feet of the Training and Conference Center. Support executive corporate initiative events. Events included corporate training, monthly coordination of event for store management training, and executive corporate staff conferences. Other events included Annual Investor Meetings, RS Board Meetings, Work with the local community to coordinate events at the Training and Conference Center. Coordinate audio visual, presentation and education events. Manage training and conference center personnel.

Provide professional support for QA VP and Director. Direct daily activities of the office. Utilized project management skills to coordinate daily, weekly, monthly and annual reports for product recovery activities. Assist with reports for tracking and trending vendor compliance. Quality Assessments of product labels. Served as HR liaison for department staff reviews, compensation, departmental restructures and other issues as needed.