Seeking experience supporting compliance with domestic and international regulatory requirements for drug administration-delivery medical devices such as: prefilled syringes, inhalers or similar.

Shall:

*** Interface with FDA, Notified Body, and other external regulatory representatives relating to: Audits, Vigilance, Medical Device Reporting, 510(k) filings, license renewals, establishment registrations, etc.

*** Generally conduct activities to support Regulatory Affairs management with the company’s compliance to FDA Quality System Regulations, ISO 13485 and related (US and International) regulations and requirements.

*** Prepares regulatory submissions and supplements, such as 510Ks, PMAs, IDE, ANDA, etc.), and device listings.

*** Plan and manage the regulatory path and requirements for the introduction of products to the market.

*** Prepare and maintain Technical Documentation Files (EU Tech Files and Design Dossiers, prepare Export Certificates (CFGs, CFS, etc.)

*** Participate in design control activities.

*** Maintain required regulatory records and track and control submissions.

*** Review and advise on labeling for compliance with regulatory filings.

*** Review product changes for impact on regulatory filings.

*** Research regulatory issues and provide guidance and advice to management.

Excellent medical, dental, vision, prescription drug, short and long-term disability, and group term life insurance. Additional benefits include certification fees paid by company for industry designations, tuition reimbursement for continued education, and more!

For details contact Patrick DiGangi at:
(609) 584-9000 ext 245

Or submit resume online at:
http://dmc9.com/pjd/app.asp

Or email to:
1000023883_10007339@jobbank301.com

Please reference #36838145 when responding.

2+ years

North Carolina

$75,000.00

$120,000.00

Patrick DiGangi

(609) 584-9000 ext 245

1000023883_10007339@jobbank301.com

http://dmc9.com/pjd/app.asp

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. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site QA Quality Assurance Regulatory Affairs Quality Engineer ISO 13485 inhalers syringes implantable surgical insertable medical devices Catheters Guide Catheters Dialators Pusher Coils Stents Inducers Wire Forms Polymer Forms Woven Structures Cardio Defibrillators Pacemakers Implants Intra-Uterine Devices Tympanostomy Tubes

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.

If you submit an application or resume which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word "remove" in the subject line to pleaseremove@candseek4.com Or, visit the website at www.jobbankremove.com. If you have further concern regarding email received from us, call (609) 584-5499.