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The QA/RA Manager is responsible for global regulatory affairs and quality system management in connection with a medical device and cosmetic products. This position is responsible for advising company management to ensure compliance with FDA and other regulatory requirements for the private labeling and distribution of a Class II medical device, cosmetics, and sunscreen products.
Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, including QSR, and ISO 13485
Conduct internal audits and provide guidance regarding best practices and continuous improvement of quality systems
Prepare the company for audit by external bodies, including FDA and notified bodies
Evaluation and management of vendors
Manage document control activities to ensure quality system documents are adequately reviewed, approved, maintained, and controlled
Manage CAPA programs and provide technical guidance for identifying and resolving quality issues
Employ quality assurance methodologies in support of marketing, product management, engineering, manufacturing, and post-market activities
Partner with CROs for product clinical trials
Review and approve elements of the product DHF, including but not limited to project plans, risk management files, verification/validation test protocols, and technical evaluations
A minimum of 5 years of quality and regulatory experience in the medical device industry
Thorough knowledge of FDA and GMP requirements and practices
Experience managing quality systems audits
Excellent organizational and project management skills with demonstrated experience in projects related to quality system implementation
Experience with start-up companies a plus
Internal Number: 1234
About Induction Therapies, LLC
A rapidly growing, start-up medical device and skin care company which manufactures and markets a cosmetic medical device and unique skin care formulations and establishes long-term relationships with clients by providing exceptional customer service, offering excellent product quality, product training, private labeling service, and ongoing customer support.