Regulatory Affairs Specialist

At Houston Methodist, the ACM Regulatory Affairs Specialist is responsible for coordinating and implementing regulatory strategies and processes to ensure timely manufacturing, and distribution of products in compliance with applicable regulations and standards. Under the direction of department leadership, this position will implement and coordinate quality and regulatory compliance programs applicable to the medical device and drug industry. Interface with the FDA and international regulatory agencies. Work with cross-functional teams to prepare regulatory submissions. Provides support during external assessments, audits, and/or inspections. Performs administrative duties required for direct supervision of Regulatory Affairs personnel and support staff.
PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.

HOUSTON METHODIST EXPERIENCE EXPECTATIONS

• Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth, dignity, and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.

• Practices the Caring and Serving Model

• Delivers personalized service using HM Service Standards

• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)

• Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience.

• Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job

• Displays cultural humility, diversity, equity and inclusion principles

• Actively supports the organization's vision, fulfills the mission and abides by the I CARE values

PEOPLE ESSENTIAL FUNCTIONS

• Participate in project team meetings and interact to advance regulatory projects.

SERVICE ESSENTIAL FUNCTIONS

• Responsible for regulatory approvals from FDA and foreign regulatory agencies.

• Oversee sponsor responsibilities for clinical trials being conducted under an IND/IDE, including and the responsibility to monitor those clinical trials.

• Review and approve regulatory specifications and protocols and study reports associated.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Ensures quality, reliability and safety of products through development and manufacturing phases.

• Assuring Methodist is compliant with all local, county, state and Federal agency regulatory requirements for medical device and drug manufacturers and that the quality system meets all regulatory requirements, including cGMP.

• Provide a critical review of regulatory submissions to ensure accuracy, adequacy, consistency and conformance to regulatory requirements.

FINANCE ESSENTIAL FUNCTIONS

• Maintain regulatory files in a compliant fashion, assuring they are audit-ready by FDA

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Coordinate and submit timely responses to regulatory agency inquiries.

• Maintain in-depth knowledge of current regulatory requirements.

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
EDUCATION

• Bachelor's degree in life sciences or related field from an accredited college or university required.

• Advanced degree preferred.

WORK EXPERIENCE

• Four years of Regulatory Affairs experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals and/or within an academic medical center setting that routinely requires regulatory submissions to FDA and other regulatory institutions.

• Regulatory audit exposure with US-FDA is required

LICENSES AND CERTIFICATIONS - REQUIRED

• N/A

LICENSES AND CERTIFICATIONS - PREFERRED

• A certification in Quality Auditing or
• ECA Certified Quality Assurance Manager -- Quality Assurance

KNOWLEDGE, SKILLS, AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security

• Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform No
• Scrubs No
• Business professional No
• Other (department approved) No

ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.

• On Call* No

TRAVEL**
**Travel specifications may vary by department**

• May require travel within the Houston Metropolitan area Yes
• May require travel outside Houston Metropolitan area Yes

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.