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.

　　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 FDAGROWTH/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/ALICENSES 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* NoTRAVEL**

　　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:

　　The Houston Methodist Academic Institute team science approach bridges the boundaries between medical specialties and research and development labs to advance the practice of medicine and population health. We innovate in health care delivery and technology by streamlining the path discoveries take into the clinic with inventive development and adoption practices. Our teams are also dedicated to training clinicians and researchers from around the world in translational medicine and advanced technology. Houston Methodist's primary academic affiliates are top-ranked Weill Cornell Medical College and the Weill Cornell Graduate School of Medical Sciences for faculty appointments and graduate programs offered on our Houston campus.

　　The Institute oversees 600,000 sq ft of dedicated space and the administrative and operational infrastructure for basic and applied research and clinical trials, including more than 20 advanced tech core facilities, extramural funding management, regulatory and legal strategy and compliance, and product development and commercialization. This infrastructure is fully integrated with our hospital systems and supports more than 50,000 learners, 700 faculty, 2000 credentialed researchers, 6,000 research projects and clinical trials that creates innovative breakthroughs in human disease and the practice of medicine every day.

　　Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.

　　Equal Employment Opportunity

　　Houston Methodist is an Equal Opportunity Employer.

　　Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.

　　Houston Methodist is an Equal Opportunity Employer.

　　Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.