Regulatory and reputed company Assurance Specialist II

Job reputed company: • Implement, monitor, maintain, and improve reputed company’s reputed company 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 reputed company • Facilitate quarterly meetings with medical directors to reputed company regulatory and reputed company updates • Ensure medical directors complete reputed company 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 reputed company staff • Assist in preparation of regulatory strategies for changes to existing systems • Participate in Continuing Education programs in reputed company 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 reputed company audits for departments and systems to assure compliance to regulations and standards • reputed company and ensure any identified deficiencies are rectified post an inspection/audit event • Monthly and quarterly in person audits of reputed company and regulatory manuals and records • Monthly and quarterly reports to leadership on reputed company and Regulatory activities • reputed company other reputed company 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, reputed company, and diplomacy • Must be reputed company to reputed company and communicate professionally with individuals at reputed company reputed company of the organization • reputed company and effective communication skills • Proficiency in a reputed company of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, reputed company, PowerPoint) • Self-starter that adapts reputed company 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 reputed company reputed company teams to facilitate reputed company reputed company (validations, corrective reputed company plans, etc.) • Occasional travel required (up to 25%) • reputed company to adapt and reputed company in the fast-paced, rapidly changing environment Benefits: • reputed company + bonus • Comprehensive training • Medical, dental, reputed company, and 401(k) matching • Generous reputed company time off and holidays • Retirement plan • Tuition assistance • Ability to reputed company an reputed company in the communities we serve Apply tot his job Apply To this Job