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At Houston Methodist, the Regulatory Affairs Specialist II position is responsible for coordinating regulatory submission filings of both investigational and marketed products utilized at Houston Methodist for patient care and research activities. This position is responsible for end-to-end compiling of information needed to support investigational applications to Food and Drug Administration (FDA) and other relevant health authorities. Along with initial filings of applications, the Regulatory Affairs Specialist II position will also maintain compliance reporting and regulatory approvals from applicable health authorities. This position will interface with the FDA and other applicable health authorities.

PEOPLE ESSENTIAL FUNCTIONS

+ Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the department.

+ Interfaces as needed with health authorities regarding product development, filing, or registration activities.

+ Maintains a professional and credible image with FDA and other regulatory agencies.

+ Initiates contributions towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.

SERVICE ESSENTIAL FUNCTIONS

+ Prepares correspondence, progress, compliance reports and other documentation relative to regulatory aspects of projects. Maintains regulatory approvals from applicable health authorities.

+ Supports sponsor responsibilities for clinical trials being conducted under an Investigational New Drug (IND)/Investigational Device Exemption (IDE).

+ Reviews and approves regulatory information contained in protocols, clinical study reports, and compliance reports.

+ Assists with execution of developed regulatory plans and interfaces with project team members, both within the organization and with a diverse range of external groups, to drive initiatives to completion.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

+ Provides substantial contribution to ensuring Houston Methodist is compliant with all local, county, state and Federal agency regulatory requirements for investigational medical device and drug applications.

+ Provides routine updates and reporting to the Director/Administrator to ensure timely communication regarding status of regulatory compliance matters.

+ Conducts critical review of regulatory submissions to ensure accuracy, adequacy, consistency, and conformance to regulatory requirements.

FINANCE ESSENTIAL FUNCTIONS

+ Works effectively with vendors and consultants to ensure services received are accurate and in accordance with executed agreements.

+ Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

+ Coordinates and submits timely responses to regulatory agency inquiries.

+ Keeps abreast of regulatory requirements, which includes monitoring FDA and other agencies regulations and standards.

+ Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.

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

+ Master's 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 investigational or marketing submissions to FDA or similar Health Authorities

+ Experience of successful submission of applications to Health Authority including Investigational Drug, Device (IND/IDE) compassionate use, pre-submission requests, market applications

LICENSES AND CERTIFICATIONS - REQUIRED

+ N/A

LICENSES AND CERTIFICATIONS - PREFERRED

+ CCRC - Certified Clinical Research Coordinator (ACRP) **OR**

+ CCRA - Certified Clinical Research Associate (ACRP) **OR**

+ ACRP-CP - Clinical Research Professional (ACRP) **OR**

+ RAC - Regulatory Affairs Certifications (RAPS)

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

+ Demonstrated knowledge and applied expertise in IND/IDE processes

+ Skilled at managing multiple projects with conflicting priorities

+ Excellent communication and interpersonal skills

+ Proficient in MS Office products (Word, Excel, PowerPoint, Outlook, Project)

+ Working knowledge of US regulations and guidance including but not limited to FDA 21 Code of Federal Regulations

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

+ Uniform No

+ Scrubs No

+ Business professional Yes

+ 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

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.

Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.

Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.

Houston Methodist is an Equal Opportunity Employer.