Director-Regulatory Affairs-DLMP

Why Mayo Clinic

Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.

Benefits Highlights

• Medical: Multiple plan options.
• Dental: Delta Dental or reimbursement account for flexible coverage.
• Vision: Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement: Competitive retirement package to secure your future.
  
  

Responsibilities

• Oversee and direct the regulatory affairs and regulatory intelligence activities within Department of Labs Medicine and Pathology (DLMP).
• Oversee implementation of the Quality Management System throughout all aspects of operations in DLMP to ensure compliance with numerous Federal, State and accreditation regulations and standards (e.g. CLIA, FDA, GxP, NYS, CAP, AABB, TJC).
• Works closely with department leadership, DLMP CPC and its subcommittees, and operations management staff to develop and implement effective regulatory strategy.
• Serve as administrative liaison for problem solving and resolution of regulatory issues between DLMP operations areas and with external clients.
• Has extensive contact with Laboratory Section Directors, Administrators, Supervisors and Trainees, both internal and external to Mayo Clinic.
• Demonstrate administrative skills and technical knowledge for effective administration of regulatory compliance and delivery of quality products and services.
• Work is self-directed. Must be able to demonstrate ability to take initiative, work independently, prioritize appropriately and assume responsibility for own decision-making.
  
  

This position is not eligible for visa sponsorship. Please note that Mayo Clinic does not participate in the OPT Stem program.

Qualifications

• Bachelor's degree, preferably in Medical Technology, Clinical Laboratory Science, or Regulatory Affairs and five years of clinical laboratory and/or regulatory affairs experience or Master’s degree in Health and Human Services, Management, Regulatory Affairs or Business and three years of clinical laboratory and/or regulatory affairs experience.
• Must have two years of demonstrated supervisory experience, preferably within a healthcare setting.
• Three years of regulatory affairs experience preferred.
• Demonstration of strong leadership, team building and problem-solving skills.
• Demonstrated ability to work with multiple disciplines, i.e., physician, administrative, supervisory and allied health staff.
• Must have excellent communication, organizational and human relations skills.
• Must be able to demonstrate ability to take initiative, work independently, prioritize appropriately and assume responsibility for own decision making.
  
  

Exemption Status

Exempt

Compensation Detail

$106,662 - $159,993 / year; Education, experience and tenure may be considered along with internal equity when job offers are extended.

Benefits Eligible

Yes

Schedule

Full Time

Hours/Pay Period

80

Schedule Details

Monday-Friday normal business hours. This hybrid role supports a combination of offsite (remote) and on-site work according to business needs. On-site expectations are 1-3 times per month as needed. The employee is required to live within commutable distance to their assigned Mayo Clinic site.

Weekend Schedule

N/A

International Assignment

No

Site Description

Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is.

Affirmative Action and Equal Opportunity Employer

As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.

Recruiter

Chelsea Crosby