Requirement Creation & Compliance Engineer – JobCode: SWDUSA291018_062018-10-29T06:11:59+00:00

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Job Title:

Requirement Creation & Compliance Engineer

Job Code:

SWDUSA291018_06

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
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