Regulatory Compliance Supervisor - Surgical Grafts & Tissue Matrices 8/26/2016
Diedre Moire Corporation, Inc
JOB DESCRIPTIONAPPLY Seeking Regulatory Compliance expertise for surgical grafts, tissue matrices, medical devices, or other biological products. Requires relocation to Florida.
*** Ability to analyze, examine, understand, and maintain compliance with local, state, federal, and international regulations for medical devices, human tissue products, and xenotransplantation products (animal cells, tissues, organs, etc.)
*** Experience developing and filing regulatory documents - 501(k)s, PMAs (Premarket Approvals), INDs (Investigational New Drug applications), BLAs (Biologic License Applications), etc.
*** Experience with 21 CFR 800 series, ISO 13485, AATB (American Association of Tissue Banks) regulations, etc.
*** Direct experience handling, investigating, and reporting adverse events to regulatory agencies.
*** Experience working with the FDA Center for Biologics Evaluation and Research (CBER).
Shall act as the key point of contact between product development teams, external regulatory representatives, suppliers, and governing bodies.
In addition to a great career opportunity within a highly rated company, the local area has plenty of exciting things to do, many places to eat, trails to hike or bike, many beautiful golf courses, and warm weather year-round.
Competitive compensation package to $115,000 per year with bonus and full company paid benefits for medical, dental and vision. Tuition reimbursement, paid training and company matched 401(k) as well as advancement opportunities within the company.
Please reference #36898130 when responding.
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Paramus
Job State Location: NJ
Job Country Location: USA
Salary Range: $65,000 to $115,000
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.
Top 10 Job Site Top 10 Careers Site Quality Compliance Specialist Regulatory Affairs Product Quality Engineer Quality Specialist Regulatory Engineer Medical Device Products Nerve Repair Reconstruction Surgical Device Graft Extracellular Matrix ECM Diagnostic Product Testing System Pharmaceutical Biotechnology Biotech FDA Food and Drug Administration 21 CFR 820 ISO 9000 ISO 13485 Tissue Bank 510k 510(k) 21 CFR 1271 GTP Good Tissue Practice Biologic CBER Center for Biologics Evaluation and Research Statistical Analysis Xenotransplantation
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.