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. • 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 • 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.
Other 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.
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 preferred. • Experience with Post-Market Surveillance and Clinical Evaluation 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.