Regulatory Coordinator - Job Opportunity at Mayo Clinic

Rochester, USA
Full-time
Senior
Posted: March 12, 2025
Hybrid
USD 83,782 - 125,736 per year

Benefits

Comprehensive medical coverage with multiple plan options, reflecting top-tier healthcare standards
Premium dental coverage through Delta Dental with flexible reimbursement options
Vision plan with extensive national network coverage
Advanced tax-advantaged savings through HSA and FSA options
Industry-leading retirement package with competitive employer contributions
Professional development and continuing education opportunities
Remote work flexibility with hybrid arrangement

Key Responsibilities

Lead regulatory compliance initiatives across laboratory divisions, providing strategic guidance and risk management expertise
Serve as departmental subject matter expert for regulatory and accreditation standards, shaping organizational policies
Coordinate and facilitate regulatory assessments while maintaining critical registrations and licenses
Develop and review regulatory documentation ensuring compliance with industry standards
Mentor and guide quality specialists and staff in regulatory requirements and quality principles
Interface with regulatory and accrediting bodies as organizational representative

Requirements

Education

Bachelor's degree in clinical/medical laboratory science (CLS/MLS), medical technology (MT), chemistry, biological science, or regulatory affairs

Experience

Six years of relevant laboratory or regulatory affairs experience; or Master's degree with four years experience

Required Skills

Regulatory compliance expertise Risk assessment and management Policy development and implementation Quality management systems Stakeholder communication Mentoring and leadership
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory complexity in laboratory operations requiring specialized expertise and dedicated oversight Growing emphasis on risk-based approaches to quality management in healthcare settings Rising importance of digital compliance tools and documentation systems in regulatory roles Expanding scope of laboratory accreditation requirements driving demand for regulatory expertise

Salary Evaluation

The offered salary range of $83,782 - $125,736 aligns with market expectations for senior regulatory roles in healthcare, reflecting the specialized expertise required and Mayo Clinic's position as a leading healthcare organization

Role Significance

Typically interfaces with 10-15 direct stakeholders across multiple laboratory divisions
Senior position with significant influence on organizational compliance and risk management strategies

Key Projects

Implementation of new regulatory requirements across laboratory systems Development of comprehensive compliance monitoring programs Risk assessment and mitigation strategy development Accreditation preparation and maintenance initiatives

Success Factors

Deep understanding of laboratory operations and regulatory frameworks Strong stakeholder management and communication skills Ability to translate complex regulatory requirements into practical processes Strategic thinking in risk assessment and compliance planning

Market Demand

High demand with growing complexity of healthcare regulations and increased focus on compliance

Important Skills

Critical Skills

Regulatory compliance expertise for maintaining operational excellence Risk assessment capabilities for protecting organizational interests Leadership skills for guiding teams and influencing stakeholders

Beneficial Skills

Project management for coordinating complex initiatives Data analysis for compliance monitoring and reporting Change management for implementing new regulatory requirements

Unique Aspects

Opportunity to work with cutting-edge laboratory systems and practices
Access to world-class healthcare expertise and resources
Involvement in shaping industry-leading compliance practices

Career Growth

Typical progression to director-level position within 3-5 years based on performance and organizational growth

Potential Next Roles

Director of Regulatory Affairs Quality Management Director Compliance Executive Laboratory Operations Director

Company Overview

Mayo Clinic

Mayo Clinic stands as a global leader in healthcare, recognized for exceptional patient care and innovative medical research

Top-ranked healthcare provider with significant influence on industry standards and practices
Major presence in the Midwest with expanding national and international footprint
Professional environment emphasizing excellence, innovation, and continuous learning, with strong focus on employee development
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