{"id":249258,"date":"2023-11-24T19:28:16","date_gmt":"2023-11-24T19:28:16","guid":{"rendered":"https:\/\/dc4a50c9a3.nxcli.io\/?post_type=product&#038;p=249258"},"modified":"2023-11-24T19:44:26","modified_gmt":"2023-11-24T19:44:26","slug":"vp-qa-ra","status":"publish","type":"product","link":"https:\/\/daysearchgroup.com\/fr\/product\/vp-qa-ra\/","title":{"rendered":"VP, QA\/RA"},"content":{"rendered":"<p><strong>Purpose:<\/strong><\/p>\n<ul>\n<li>To lead the company in all matters of quality assurance and regulatory affairs and act as the face of the company to the FDA for all compliance issues.<\/li>\n<\/ul>\n<p><strong>Duties &#038; Responsibilities:<\/strong><\/p>\n<ul>\n<li>Responsible for leading company product quality and reliability process, systems, and culture to meet and exceed customer expectations.<\/li>\n<li>Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals.<\/li>\n<li>Adheres to the Integer Values and all safety and quality requirements including but not limited to EN ISO13485, the EU Medical Device Regulation and 21 CFR Part 820.<\/li>\n<li>Support all aspects of the centralized Regulatory Affairs function for the assigned Product Category including product registration, customer support and post-market surveillance.<\/li>\n<li>Responsible for Product Category level leadership, planning, coordinating, communication, organizing, coordinating, budgeting, staffing, metrics, and achievement of performance standards.<\/li>\n<li>Serves as principal Quality contact and advocate to customers in assigned Product Category and represents Quality Assurance in Product Category customer business reviews, executive partnership meetings and customer escalation events.<\/li>\n<li>Reviews and approves Customer Quality Agreements for sites and product category in alignment with Enterprise QA\/RA and the Legal function.<\/li>\n<li>Through leadership of site Quality management and Operations, ensures that all key quality metrics are used to drive continuous improvement and that agreed improvement targets are attained as the result of clearly defined action plans.<\/li>\n<li>Lead the Design Assurance management team within support of new product development.<\/li>\n<li>Collaborate with Engineering to assure robust designs that result in safe and effective products of superior quality.<\/li>\n<li>Identify, resolve, or escalate any and all product, process or customer quality related issues that pose risk with respect to the patient, customers or compliance.<\/li>\n<li>Interviews, hires, and establishes training plans for direct reports and holds managers accountable to do the same. Provides leadership to assigned staff regarding development of individuals\u2019 goals and mentoring of the group.<\/li>\n<li>Provide regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US and international laws and regulations.<\/li>\n<li>Direct long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.<\/li>\n<li>Manage internal and external regulatory procedures to ensure compliance.<\/li>\n<\/ul>\n<p><strong>Knowledge &#038; Skills Required:<\/strong><\/p>\n<ul>\n<li>BS in engineering, technical or related discipline. Master\u2019s degree preferred.<\/li>\n<li>Minimum of 12 years of experience in Quality Assurance in a medical device development and manufacturing environment. Minimum of 5 years of direct management experience in a medical device development and manufacturing environment.<\/li>\n<li>Extensive experience with product development, design verification, validation, and risk management.<\/li>\n<li>A successful track record with game-changing first-of-a-kind product launches.<\/li>\n<li>Team player with excellent communication skills, both written and verbal.<\/li>\n<li>Flexible to work long hours as required.<\/li>\n<li>Experience with robotic surgery product development.<\/li>\n<li>Experience in the dental implant industry.<\/li>\n<li>Start-up experience.<\/li>\n<li>Experience with the following regulations (preferred):\n<ul>\n<li>FDA 21 CFR Part 820 \u2013 FDA Quality System Regulation<\/li>\n<li>ISO 13485 -Medical Devices Quality Management Systems \u2013 Requirements for Regulatory Purposes<\/li>\n<li>European Medical Device Directive 92\/43 EEC<\/li>\n<li>CAN\/CSA-ISO 13485 \u2013 Medical Devices \u2013 Quality Management Systems<\/li>\n<li>Canadian Medical Devices Regulations (CMDR)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Physical Requirements:<\/strong><\/p>\n<ul>\n<li>Able to work in an industrial environment.<\/li>\n<li>Capable of lifting at least 50 lb of weight.<\/li>\n<\/ul>\n<p><strong>Location: Miami, FL<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Miami, FL<\/p>\n<hr \/>\n<p>Job# 861<\/p>\n","protected":false},"featured_media":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"off","_et_pb_old_content":"<strong>Overview<\/strong>:\r\n\r\nOur global dental client is expanding! They are hiring Territory Managers in the following areas :\r\n\r\nAtlanta, GA | Bay Area, CA | Dallas, TX | Los Angeles, CA | Seattle, WA | Toronto, ON | Vancouver, BC\r\n\r\n<strong>Job Summary: <\/strong>\r\n\r\nResponsible for achieving or exceeding your sales quota and service goals in dental\/dental surgery offices and dental labs within your assigned territory-marketing area through the effective selling and promoting the company\u2019s products. Must use products, solutions, and services to existing and potential new customers within the framework of organizational policies and directions.\r\n\r\n<strong>Responsibilities: <\/strong>\r\n<ul>\r\n \t<li>Develop and implement a sales plan for existing and potential new customers, access their needs and characteristics. Present appropriate, products, solutions, and services.<\/li>\r\n \t<li>Coordinate your sales plan with your Area Director.<\/li>\r\n \t<li>Analyze and assess customer needs and current sales trends. Plan sales activities based on territory targets to attain or exceed assigned monthly, quarterly and annual sales goals.<\/li>\r\n \t<li>Maintain regular contact with existing customers to strengthen relationship and ensure satisfaction with products, solutions and services. Expand\/grow core business.<\/li>\r\n \t<li>Identify and maintain regular contact with prospective customers, develop and implement creative and effective strategies aimed at converting these prospective customers into a new customer.<\/li>\r\n \t<li>Develop and maintain relationships with key influential dental leaders. Utilize these relationships to expand your market share.<\/li>\r\n \t<li>Develop and maintain accurate customer files and records to complete up\u2013 to-date information with your customers and Area Director.<\/li>\r\n \t<li>Study and stay informed on products, technologies, clinical studies, competitive activity information that be shared with your customers and company.<\/li>\r\n \t<li>Maintain a comprehensive knowledge of all company policies and procedures and demonstrate the ability to effectively implement in your territory.<\/li>\r\n \t<li>Establish and maintain a travel schedule for your sales plan within your allocated expense budget.<\/li>\r\n \t<li>Complete all administrative reports in a timely manner.<\/li>\r\n \t<li>Participate in local trade shows and company meetings. Support and establish educational programs within your territory that local customers are attending.<\/li>\r\n \t<li>Demonstrate ability to digest, to comprehend and verbalize highly technical product and clinical information related to the company and industry products.<\/li>\r\n \t<li>Demonstrate professional sales skills.<\/li>\r\n \t<li>Strong verbal and written communication and interpersonal skills.<\/li>\r\n \t<li>Intermediate computer skills.<\/li>\r\n<\/ul>\r\n\u00a0\r\n\r\n<strong>Qualifications:<\/strong>\r\n<ul>\r\n \t<li>Bachelor's degree or equivalent<\/li>\r\n \t<li>Minimum of 2 years sales experience preferred in a direct dental sales environment<\/li>\r\n \t<li>Excellent communication and interpersonal skills<\/li>\r\n \t<li>Proven successful track record in capital, medical, and\/or dental equipment sales<\/li>\r\n \t<li>Ability to travel up to 75%<\/li>\r\n \t<li>Success in introducing new technologies to the market<\/li>\r\n \t<li>Must be an \u201cout of the box\u201d strategic thinker<\/li>\r\n \t<li>Start-up experience preferred<\/li>\r\n \t<li>Dental and\/or private practice experience preferred<\/li>\r\n<\/ul>","_et_gb_content_width":"","inline_featured_image":false},"product_brand":[],"product_cat":[31,38,28,29,32,49,26],"product_tag":[],"class_list":{"0":"post-249258","1":"product","2":"type-product","3":"status-publish","5":"product_cat-executive","6":"product_cat-florida","7":"product_cat-geography","8":"product_cat-job-function","9":"product_cat-open","10":"product_cat-regulatory-affairs","11":"product_cat-status","13":"first","14":"instock","15":"shipping-taxable","16":"product-type-simple"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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