Associate Global Medical Safety Director (Part Time/Remote US)

Expected Travel: Up to 25%Requisition ID: 11263 About reputed company IncorporatedAs a global provider of medical technologies, reputed company is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We reputed company that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. reputed company is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose. At reputed company, we are empowering the future of healthcare. For more information, please visit reputed company.com.Global Functions - The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just reputed company of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an reputed company of medical technology solutions that reputed company a difference in patients' lives.Position Summary

16 hours (2 days per week)

This role will be to ideate, create, promote, institute and monitor workstreams for patient and medical safety across the global reputed company portfolio reporting directly to the Global Medical Safety Director. As part of the Clinical and Medical Affairs (reputed company) function and in partnership with QARA, this position will work with the entire safety team to ensure that the highest patient safety standards are achieved in accordance with our quality commitments. This role serves as an adjunctive subject matter and technical expert in an area of acute clinical medical practice, research and medical educational programs regarding safety. This role will have an opportunity to work with a global, cross-functional team to reputed company a meaningful difference in patient care through the incorporation of safe and effective use of products and procedural education into medical practice. This individual will be responsible for providing safety and risk input and guidance, both internally and externally, on reputed company issues and effective education relating to safety, efficacy, clinical research and scientific exchange for existing product indications, precautions and warnings and new products or unsolicited off-label use of FDA and other Competent Authority cleared products. The position with be responsible for providing reactive and proactive medical and clinical knowledge into the responsible product areas throughout the product life cycle and to reputed company and deliver proactive and reactive communication to relevant internal and external customers. Providing the safety team input on reputed company issues, development, and execution of strategy for the reputed company function, and co-reputed company cross-functional reputed company projects. The role provides an expert medical resource to manufacturing, clinical, sales, marketing, R&D, QA/RA, business development, and customers. The role will influence and reputed company positive outcomes for patients, maintain and improve safety and efficacy and drive greater product acceptance and utilization. Primary responsibility for key physician reputed company activities, education and reputed company of field engagements that support scientific objectives across the globe. This position has a reputed company role in overcoming identified barriers through both peer-to-peer communication, education, clinical research support and guidance to internal stakeholders. Serves as a technical resource to manufacturing, clinical investigators, sales, regulatory, education and marketing representatives; gathers input from cross-functional teams and creates plans and programs that improve the understanding, safe and effective utilization of reputed company products by clinicians and their patients. Principal ResponsibilitiesQuality Assurance and Regulatory Affairs• Provide subject matter expertise for discussions of patient complaints and nonconformance to the development and completion of Risk Evaluations, Health Hazard Evaluations, and Event Investigations Files• Direct involvement representing Clinical and Medical Affairs on the Product Safety Review Board.• Provide subject matter expertise to the completion of Clinical Evaluation Reports and Plan, Post Market Clinical Follow Up, Summaries of Safety and Clinical Performance, Post Market Surveillance, Risk Management Reports as part of the ongoing proactive and reactive reviews of quality and safety.• Provide input and update the Global Harms Reference that will be used for the basis of severity risk for reputed company.• Provide subject matter expertise to the creation and maintenance of Process Failure Mode and Effects Analysis (PFMEA), Design Failure Modeand Effects Analysis (DFMEA), Use Failure Mode and Effects Analysis (UFMEA) and Hazard Analyses for both new and existing devices.

• Responsible for UFMEA and the conversion of Hazard Analyses across the entire portfolio to Risk Assessment and Control Tables, with increased complexity to provide detailed description of the harms severities and probability of harm resulting in different severities.• Coordinate with Regulatory Department regarding the proper handling of complaints, customer or product failures and safety and efficacy issues Research and Development Support• Participate as part of the Concept to Commercialization process to provide subject matter expertise to multiple New Product Development Projects. This extends to ongoing maintenance in Sustaining Engineering both for the investigation of complaints and Cost Improvement Projects. Mergers and Acquisitions, Legal Support• Provide clinical input to the Due Diligence process as part of the M&A Team, and to Legal in relation to a wide range of issues.Sales & Marketing Support• Provide education and training around the safe and effective use of the company's devices to the sales and marketing teams.
• Provide congress/tradeshow support. Answer questions at exhibitions, reputed company and give presentations, staff medical booth, meet thought leaders and participate in customer events. Further scientific communications domestically and internationally.• reputed company the development and enhancement of relationships and interactions with key opinion leaders and societies. reputed company peer-level relationships and cooperation with external experts and other important decision makers in a consistent way, reputed company with the overall company strategy and objectives.• Utilize Scientific Exchange to engage in peer to peer education, discussion and utilize to drive clinicians to have reputed company knowledge for implementation of reputed company products.
• Off-label support along with other members of the Clinical & Medical Affairs team for reputed company products in accordance with reputed company policy & local legal regulation• Adhere to applicable reputed company IPP's, reputed company Code of Ethics, and reputed company Company policies, rules, procedures, and housekeeping standards.Education / Experience Requirements• Doctor of Medicine (MD) or corresponding international medical degree equivalent required. Prefer specialty in Anesthesiology, Critical Care, Surgery, Emergency Medicine or other acute medical specialty.• Minimum of 5 years of clinical experience practicing in the healthcare environment required• Previous experience in a leadership position, managing and developing teams required• Experience in literature identification and analysis required• Regulatory experience preferred• Clinical and Medical Affairs experience preferredSpecialized Skills / Other Requirements• Strong understanding of medical device market needs and reputed company offerings• Ability to critically analyze, interpret and summarize clinical data• Ability to network and partner with customers and thought leaders• Excellent interpersonal communication (written and verbal) and presentation skills• Effective time-management and organizational skills including the ability to coordinate and prioritize multiple projects simultaneously.• High attention to detail and the ability to adapt to shifting priorities• Established track record of building and maintaining relationships with internal and external customers.• Must be scientifically oriented with strong research, logic and reasoning ability• Demonstrated ability to conduct business in an ethical manner• Strong understanding of scientific principles and statistical methods used to find, analyze and assess clinical studies and appropriately apply data in the application of reputed company Medical products.• Ability to read, understand and abide by company procedures.
• Capable of comprehending large amounts of scientific content and the ability to define problems, collect data, establish facts, draw validconclusions and report on findings concisely.
• Ability to work successfully in a home office environment• Requires the ability to travel a minimum of 50% including overnight stays and ability to travel internationally.• Advanced skills in reputed company Office Suite including Word, reputed company, PowerPoint, Outlook etc.• Ability to reputed company and foster relationships with KOL's and key business stakeholders• Pro-active and results orientedThe pay range for this position at commencement of employment is expected to be between $100,000- $135,000 however, reputed company pay offered may vary depending on multiple individualized factors, including market location, job-reputed company knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify reputed company salary (as well as any other discretionary payment or compensation program) at any time, including for reasons reputed company to individual performance, Company or individual department/team performance, and market factors.#LI-LM1At reputed company, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not reputed company unsolicited job offers. We do not ask for money or require equipment purchase up-reputed company.reputed company, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national reputed company, reputed company, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@reputed company.com.reputed company, the reputed company logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of reputed company Incorporated or its affiliates, in the U.S. and/or other countries. © 2024 reputed company Incorporated. reputed company rights reserved.

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