Medical Device Regulatory Affairs Administrator
*** Identifying, evaluating, and ensuring compliance with laws, regulations, and standards.
*** Ensuring quality of products through quality control tests and inspections and engineering change order support by applying design controls, risk management methods, and associated processes, policies and procedures.
*** Evangelizing the quality policies and continual improvement.
*** Provide management with detailed review reports, official recommendations, and gap analyses for new and revised enactments.
*** Conduct supplier quality management activities.
*** Coordinate and conduct internal and 3rd party quality audits and inspection activities (ISO, FDA, etc.)
*** Collecting, maintaining and reporting pertinent metrics.
*** Ensuring that reasonable risk management controls are in place.
*** Reviewing work and rework order fulfillment activities to ensure accurate and satisfactory completion.
*** ValidatingEngineering Change Requests and Orders to ensure sound engineering practice, effective and adequate design, product safety, and quality system compliance.
Competitive compensation with yearly bonus structure and generous company paid medical, health, dental, vision, and prescription drug benefits and long-term incentives including 401(k) with "dollar for dollar" company matched contribution and more. Career oriented company with fantastic work-life balance and quality of life focus.
Please reference #36899137 when responding.
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 2-5 years
Job City Location: Springfield
Job State Location: MA
Job Country Location: USA
Salary Range: $70,000 to $110,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. Top 10 Job Site Top 10 Careers Site QC QA Quality Control Quality Assurance Regulatory Affairs Quality Management System ISO13485 FDA cGMP Medical Device Audit MRB Materials Review Board 510(k) 510K DHR Device History Record DMR Design Master File Risk Analysis Risk Management Clinical Instrument Clinical Diagnostic Medical Equipment General Medicine Endoscope Camera Penlight
DISCLAIMER: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.
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