Aspen Surgical is a leading worldwide manufacturer of disposable surgical supplies with an emphasis on safety. Our extensive portfolio of specialty medical products includes Bard-Parker® Blades and Scalpels, O.R. Accessories, Patient and Staff Safety Products, Wound Care Products, and Instrument Care Products. Description ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned Market Clearance: * Determine requirements and generate market clearance applications, as needed, for US and OUS which may include 510(k), STED Files, Design Dossiers and similar submissions for ROW (Rest of World). Support Global Expansion & in-country RA personnel for ROW global product registrations. Create and maintain product summary technical documentation (STED) to support global product registrations. * Supports international registration activities required by our customers or international distributors * Assess the acceptability of quality, preclinical and clinical documentation for submission filing * Ensures annual Regulatory activities are completed (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses) * May serve as primary interface with the notified body including relationship management, audit scheduling, and related follow-up activities * Manages ISO and CE certifications to ensure all required internationally sold devices are accurately depicted * Reviews labeling, IFU's, advertising, promotional items, sales and marketing literature to ensure all comply with related standards * Provides Regulatory support for New Product Development which includes product classification review and regulatory submission requirements * Responsible for supporting research, development, and sustaining engineering teams on required medical device performance and safety standards. Review scientific/engineering materials (protocols/reports), support continuous improvement activities and provide regulatory assessment on proposed changes to marketed devices * Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of QA/RA and related teams * Participates in Risk Management and Post Market Surveillance as part of a cross-functional team * Monitors and submits applicable vigilance reports and ensures appropriate responses are submitted to regulatory authorities * Responsible for keeping the product portfolio in compliance with worldwide standards and regulations by maintaining awareness of changing global regulatory requirements / technical publications and communicating the impact to internal teams to implement the required updates. Facilitates communication and tracking of changes to regulations and standards by creating, maintaining and updating a library of information. * Supports regulatory projects and OUS regulatory relations with Authorized Representatives and In Country Caretakers * Reviews and approves customer and distribution QA/RA contracts to ensure conformance and accuracy of content * Provides assistance in product notification and recall activities * Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies * Manages product change control to ensure regulatory compliance is maintained throughout changes Qualifications EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS: * Bachelor's Degree or equivalent job experience; M.S. in a technical area or M.B.A. is preferred * Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is a plus * 5+ year work experience in a regulated industry (e.g., medical devices, combination products) * 5+ years' experience in regulatory affairs and/or product development in medical devices Medical device, biological, or pharmaceutical environment preferred * Note: Higher education may compensate for years of experience * Must have knowledge of ethical guidelines of the regulatory profession, clinical research and regulatory process * Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents; principles and requirements of applicable product laws NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation Please refer to the Essential Duties and Responsibilities. Aspen Surgical is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity
Employer's Job# 73849685
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