|The Company is a pioneer in medical robotics and world leader in image-directed, robotic products for orthopedic applications. The Company’s product allows surgeons to pre-operatively plan their surgery in a 3-D virtual space and then execute the surgery in the operating room, exactly as planned.
The manager of Regulatory Affairs is responsible for developing strategies for worldwide governmental approvals/clearances to introduce new and modified products to the market, advises on regulatory requirements, prepares worldwide regulatory submissions, and negotiates product approval. To ensure compliance with all applicable domestic and international (US and out of US) regulations and requirements. Experience within the medical device industry with knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulations (QSRs), International Organization of Standardization (ISO) 13485:2003, Medical Device Directive (MDD) 93/42/EEC and ISO 14971:2007. The incumbent has the ability to take strategic direction and establish efficient and compliant processes throughout the organization and has strong communication at all levels.
?10% Training opportunities, Regulatory Agency meetings, Distributors, Clinical Sites, Suppliers.
?Plan, coordinate and prepare documents packages for regulatory submissions, including FDA 510(k), IDE, PMA(s), Design Dossiers, Shonins, Device License Applications, and internal Letters to File. Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process. Prepares complex submissions to gain approvals for, export, and commercial distribution for device such as: IDES, IDE Progress Report, Clinical Trial Submission, 510(k), PMA, PMA-S, PMA Annual Report, HUD Designation, HDE< Shonin, Design Dossiers, and CE-Mark Technical File. Negotiate directly with the Regulatory Agencies on applicable products/projects. Develop and implements regulatory strategies for new and modified products.
?Responsible for foreign registrations and Permission to Export documents. Maintain submission correspondence files and other regulatory files in a complete and secure manner. Create project deliverables, aligned with appropriate internal and external guidance documents. Maintain annual facility registration and device-listing documents. Ensure that existing approvals and documents are maintained. Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing or major business segment products lines, special projects or strategic initiatives.
?Review and approve regulatory submissions and approvals, including design and manufacturing changes, labeling, web page content, and advertisements. Provide regulatory input in quality system assessments, product development, and complaint/MDR/Vigilance handing system. Review and approve test protocols to support regulatory submissions. Support the CTC Quality Policy and Quality System. Provide input on and reviews Design Control documentation such as: Risk Management, design verification, design validation, shelf life studies, pre-clinical studies, and clinical studies. Monitor and research changes in the regulatory and competitive environment, evaluate impact and communicate to interested parties. Provide regulatory feedback and guidance throughout the product development cycle, and coordinate team inputs for submissions on manufacturing and development teams.
?Initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, under minimal direction, up to and including travel to, and direct discussions with the appropriate regulatory agency. Act as company representative, develop and maintain positive relationship with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
?Provide project, department, and company guidance and training based on current and emerging regulatory affairs and requirements, regulations, and processes, and focus on improved regulatory efficiency and effectiveness. Provide technical guidance and regulatory training, mentoring to other Regulatory Affairs employees and cross-functional teams. Develop and implement departmental and divisional policies and procedures. Participate on Corporate initiatives as appropriate.
?Other duties as assigned.
?Bachelor's degree and a minimum of 10 years experience in the medical device industry and 4 years in a management role.
?Demonstrated success in a start-up, entrepreneurial work environment.
?Through knowledge of FDA Quality system requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971:2007 (Risk Management) requirements, Medical Device Directive (MDD) requirements, and knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
?Through understanding of:
?Awareness of international regulatory requirements and systems.
?8+ years Regulatory Affairs medical device industry experience.
?Demonstrated expertise in management of regulatory submissions activities.
?Demonstrated project management skills and experience.
?Proficient in timely review of technical and clinical data.
?Proficient in FDA and international regulations.
?Technical knowledge of medical devices.
?Ability to write clear, concise, and well thought out technical documents.
?Ability to take leadership role in regulatory and/or cross-functional team.
?Strong leadership, organizational, interpersonal skills
?Good presentation skills.
?Computer skill: MS Word, PowerPoint, MS Project, Adobe Acrobat, Visio, Excel, Database.
?FDA medical device regulations, guidance, and import/exports requirements
?Medical device labeling and promotional requirements
?Product development processes
|Curexo Technology Corporation|
State or Province