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US Fertility · 1 month ago

Regulatory and Quality Assurance Specialist II (Remote)

United States

Full-time

Remote

Mid Level

US Fertility is the nation’s largest partnership of physician-owned and physician-led top-tier fertility practices, dedicated to delivering the joy of parenthood through advanced reproductive medicine. The Regulatory and Quality Assurance Specialist II is responsible for reviewing and implementing regulatory aspects and quality systems to ensure compliance with all relevant regulatory agencies.

Health CareHospital

Responsibilities

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

Qualification

Quality System ManagementRegulatory ComplianceDocument ControlLaboratory ExperienceData AnalysisMulti-tasking AbilitiesInterpersonal SkillsCommunication SkillsOrganizational SkillsTeam Collaboration

Required

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

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

The successful candidate will have the ability to work well independently, as well as part of a team

Excellent multi-tasking abilities