Manager, Regulatory Affairs

Overview:

This role is responsible for creating, documenting, training, implementing and analyzing processes that ensure compliance with regulatory and company standards. Lead compilation of documents and responses for regulatory audits, report record audits and maintenance of records required for certifications/inspections.
Responsibilities:
Management of related areas including implementation of procedures and processes to support regulatory requirements across Diagnostics Services organization.
Ensure that research is done at least annually on all regulatory, licensing and permitting requirements. Monitor published guidelines for revisions to regulations, licensing, permitting and/or accreditation standards and ensure operational compliance. Update SOPs and Job Aids as needed. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations.
Collaborate with Diagnostic Services teams to ensure that personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.
Responsible for communicating and training on regulatory compliance with all applicable federal and state laws, regulations, policy directives and ethical requirements for Diagnostic Services operations.
Respond directly to internal/external customers regarding regulatory policies/requirements and assist them in finding solutions to business problems.
Ensure permitting requirements are communicated and met for on-site screening and immunization clinics for Diagnostic Services clients nationwide.
Ensure that all required licenses are identified and maintained as necessary for the operation of health screening and immunization clinics.
Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed and corrective action is completed for all non- conformances.
Assist in addressing Legal and Compliance issues related to regulatory requirements in conjunction with corporate departments.
Coordinate document assembly and responses for third-party reimbursement or privacy/security audits for Diagnostic Services customers.
Determine that no deviations from approved protocols or SOPs in regulatory process requirements were made without proper authorization and documentation.
Ensure that documentation for all operational areas (SOPs and job aids) is current, is refreshed at least annually to reflect the regulatory requirements and is posted in SmartSolve for everyone to access as needed. Train on any changes as necessary.
Provide guidance to operations on complex regulatory issues and partner on solutions.
Establish and manage to Operating Mechanisms that support regulatory compliance.

Qualifications:
Required Work Experience:
Demonstrated experience leading regulatory and /or compliance projects.
Preferred work Experience:
Minimum of 5 years technical laboratory or regulatory experience with point of care, laboratory, and immunization distribution regulations.
Skills:
Strong verbal and written communication skills.
Demonstrated success in collaborating effectively with internal and external team members to reach objectives.
Strong influence skills and excellent interpersonal skills.
Demonstrated PC experience with MS Word, Excel and PowerPoint.
EDUCATION
Bachelors Degree(Required)
EEO:
Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other status protected by state or local law. Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.

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