Quality Assurance Associate

Company: American Surgical Company Job Title: Regulatory Affairs and Quality Assurance Associate Location: Salem, MA Summary: Regulatory Affairs and Quality Assurance Associate is responsible for identifying, evaluating, and ensuring compliance with all applicable laws, regulations, and standards. The Regulatory Affairs and Quality Assurance Associate shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, and support in all chosen distribution markets. Essential Duties and Responsibilities : Remain aware of new or updated regulations, laws, standards and other official enactments that may apply to the company. Provide detailed analysis, official recommendations, and gap analyses for new or revised standards and regulations. Manage medical device adverse and field corrective actions reports and recall notifications. Ensure adequate compliance schemes associated with all regulatory compliance systems, as required by law. Support Establishment and Device registration applications. Support preparing IDE, 510(k), PMA, CE Mark, and other related regulatory filings. Create Global Trade Identification Numbers (GTIN), updating, and maintaining labeling databases such as Access GUDID and Eudamed. Represent the company as formal escort or other role in internal and external audits and other regulatory agency interactions. Obtain and maintain company ISO and CE Certification, as appropriate. Assist, document, and implement regulatory strategy for new technologies and product modifications. Establish and implement necessary policies, procedures, templates related to Regulatory Affairs and Quality Assurance Assisting in the training on policies, procedures, and forms for their use. Revise documents as needed and coordinate review and approval of SOPs, specifications, and forms. Ensure completion of appropriate quality management systems, mechanisms, and record-keeping. Ensure completion of company training and record-keeping. Prepare and present regulatory and quality content for Management Review. Administer and coordinate the review and approval of all ASC's documents required by all applicable regulatory agencies. Administering timely and appropriate distribution of documents (Assure updated documents are available and used.) Establishing and/or administering a documentation filing system for all policies, procedures, specifications, and/or forms. Establishing and maintaining best practices in handling of documents. Creating, reviewing, collecting, updating, storing, retrieving, securing, controlling revisions and destruction of old records. This is typically done both for physical and electronic documents to ensure that official records are kept secure, up-to-date, and readily retrievable. Identify training needs and act to ensure company-wide compliance. Prepare ad-hoc reports on projects as needed. Skills and Abilities: Ability to use office copier and computer required. Prior experience using Microsoft Word, Excel and PowerPoint preferred. Demands ability to evaluate situations and plan appropriate actions. Requires skill in dealing diplomatically and professionally with employees representing all levels of organization. Requires excellent verbal and written communication skills as well as attention to detail and the ability to initiate and complete projects within required timeframes. Must be able to work well under limited supervision. Ability to perform detail-oriented work, coordinate multiple projects, perform presentations, and adapt to a flexible environment with changing daily workload and priorities as directed. Organizational skills to track open items, persistence in follow-up and solid time management skills. Education and Experience: Bachelor's degree, desire in clinical, engineering or scientific discipline 3-5 years relevant experience in a similar position in a regulated medical device manufacturing environment. Excellent public speaking, professional writing, typing, and general office application skills are essential for substantial cross-organizational interaction and facilitation, as well as process and record generation. Excellent English written and verbal communication skills are essential. Experience with EU MDR, ISO13485, FDA 510(k), and PMA preferred. Experience with medical devices and medical equipment is preferred. Experience with Post-Market Surveillance and Clinical Evaluation preferred. ISO13485 Internal Auditing certification preferred. Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.