Careers

Job Description

• 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

Minimum Requirements

• ·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)

Mandatory Skills

• IEC-62304 compliance experience

Location

• Plano, TX

Package

• Highly competitive to match experience and capability