Regulatory and Quality Assurance Specialist II

Job Description: • Implement, monitor, maintain, and improve the company’s Quality System • Implement, monitor, and maintain a document control system • Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed • Assure appropriate licensure is held and maintained by the company • Facilitate quarterly meetings with medical directors to provide regulatory and quality updates • Ensure medical directors complete all signoffs as required • Assure compliance to international regulatory agencies • Tracking and trending of laboratory, cryogenic, andrology, and deviation systems • Maintain and improve deviation/non-conformance system • Report events to regulatory bodies as applicable • Assure training and competency of all staff • Assist in preparation of regulatory strategies for changes to existing systems • Participate in Continuing Education programs in related field • Participate in planning and implementation of regulatory systems, document/change control and validation activities • Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies • Implement and oversee audits for departments and systems to assure compliance to regulations and standards • Track and ensure any identified deficiencies are rectified post an inspection/audit event • Monthly and quarterly in person audits of quality and regulatory manuals and records • Monthly and quarterly reports to leadership on Quality and Regulatory activities • Perform other related duties as assigned by management Requirements: • Bachelor’s degree or equivalent combination of training and experience • Must have a high level of interpersonal skills to handle sensitive and confidential situations. • Position continually requires demonstrated poise, tact, and diplomacy • Must be able to interact and communicate professionally with individuals at all levels of the organization • Clear and effective communication skills • Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint) • Self-starter that adapts well to change in a fast-paced, dynamic environment • Prior laboratory experience preferred • Knowledge of industry, Federal and State regulations, licensing processes • Strong aptitude for analyzing data, audit processes and reconciling records • Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes • Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships. • Excellent verbal & written communication skills • Ability to work as part of a multi-disciplinary team • Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.) • Occasional travel required (up to 25%) • Able to adapt and thrive in the fast-paced, rapidly changing environment Benefits: • Competitive pay + bonus • Comprehensive training • Medical, dental, vision, and 401(k) matching • Generous paid time off and holidays • Retirement plan • Tuition assistance • Ability to make an impact in the communities we serve Apply tot his job Apply To this Job