Requirement Creation & Compliance Engineer
Responsible for facilitating client Requirement Analysis Sessions. Under minimal direction, formulate and define scope and objectives based on both client’s needs and a good understanding of information technology, business processes, and industry requirements.
Act as a liaison between client and technical solutions/ support groups, using advanced communication skills to elicit, document, analyze and validate client requirements.
Coordinate, prepare, and technically review data or reports for regulatory submissions for projects.
Coordinate with manager to develop and implement regulatory plans to ensure full compliance with regulatory agencies (e.g. FDA, and others) and with internal standards.
Assist in the formulation of policies and procedures; understand and interpret policies, procedures, and regulations; edit and coordinate editing of policies.
Prepares compliance audit data by compiling and analyzing internal and external information.
Development and execution of the internal compliance program including preparation for audits, certifications, and risk assessments
Supports departments by collecting and coordinating internal compliance data with auditors and various departments.
Post market surveillance including complaint monitoring, tracking and trending, and vigilance reporting
Help guide and perform remediation of issues identified during third-party assurance or internal reviews
Researches regulations by reviewing regulatory bulletins and other sources of information.
Aware of Mobile Application domain and about various Apple iOS releases
·Bachelor’s degree, preferably in Engineering or Health Care area. Able to apply structured thinking to problem solving.
4-5 years’experience in medical devices and Neuro-modulation domain
Experience with ISO 9001, ISO 13485, ISO14971, ISO 27001 and FDA QSR for Medical Devices (Certification in Healthcare Compliance preferred)
Proficient with auditing techniques
Excellent interpersonal skills and demonstrable ability to work with diverse functional areas within the organization.
Excellent time management skills, extremely self-directed.
Excellent writing and editing skills; Proficiency with Microsoft Office (Excel, Word, Access, PowerPoint, Project)
- IEC-62304 compliance experience
- Plano, TX
- Highly competitive to match experience and capability