Regulatory Affairs Representative - Xenotransplantation
Seeking Regulatory Affairs specialist with experience in products such as animal cells, tissues, or organs used to treat human diseases when human materials are not available.
Position requires relocation to Florida - a beautiful place to live with a large number of some of the world's best golf courses, biking and hiking trails, beaches, theme parks, and more!
*** Assess the existing regulatory affairs compliance and quality system and implement improvements to reduce or eliminate regulatory compliance risks.
*** Conduct internal audits and interface with third party auditors from the FDA and other regulatory organizations.
*** Maintain required regulatory records and track and control submissions.
*** Review product changes for impact on regulatory filings.
*** Maintain biologic product filings and Biologics License Applications (BLAs).
*** Examine and ensure adherence to updates or changes to FDA or other regulatory agency requirements for xenotransplantation products (cells, tissues organs, etc.)
*** Maintain licenses for state, local, and federal agencies.
*** Regulatory Affairs and Compliance experience with investigational or licensed xenotransplantation products such as cells, tissues, or organs - OR - other biological products including medical devices, human tissues and cellular products, etc.
*** Experience interfacing with representatives from the FDA Center for Biologics Evaluation and Research (CBER).
*** Experience with 21 CFR 800 series (Medical Devices - General), 600 series (Biological Products: General), 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products), etc.
Excellent opportunity with generous benefits and starting salary to $115,000 with end of year bonus. Excellent health, medical, dental and vision insurance packages, company matched 401(k) and paid time off for vacations, personal days and sick days, company paid training and paid holidays.
Please reference #36898100 when responding.
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Huntsville
Job State Location: AL
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.
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.