*Hi* *Please go through the below position and if you feel comfortable, then please send me your updated resume*
*Role: PMA Regulatory* *Interview: Phone then F2F* *Duration: 6+ months* *Location: Marlborough MA* *Job Description:* *****Need someone really strong with PMAs****** *****MUST HAVE MEDICAL DEVICE EXPERIENCE w/ Class II and Class III******** *Experience with 510ks submission – just involvement will do (no need for someone who has wrote one from scratch)* Premarket Approval (PMA) for high-risk Class III medical devices and some innovative technology where no identifiable predicate exists. The FDA PMA approval process is more complex and time-consuming than 510(k) premarket notification <http://www.emergogroup.com/services/united-states/fda-510k-consulting>, and requires considerable preparation and resources. There are five general components to the FDA PMA approval process for medical devices: - Pre-Submission (pre-sub) - Investigational Device Exemption (IDE) - Premarket Approval - Quality System Inspection to 21 CFR Part 820 - Registration of your medical device with FDA Emergo consultants can support each phase of your FDA PMA approval effort, including pre-submission collaboration with the FDA, clinical trial management, quality system compliance and final FDA registration. [image: logo] *Ankush Nirala* | Technical Recruiter | Apetan Consulting LLC Tel: 201- 620- 9700* 112 | Mail: 72 Van Reipen Avenue # 255 Jersey City, NJ 07306 | Corp.Office: 15 Union Avenue, office # 6, Rutherford, New Jersey 07070 | [email protected] | G-talk: [email protected] | www.apetan.com *[image: https://s3.amazonaws.com/images.wisestamp.com/icons/facebook.png]* <http://www.facebook.com/Apetanconsulting> *[image: https://s3.amazonaws.com/images.wisestamp.com/icons/linkedin.png]* <http://www.linkedin.com/company/apetan-consulting-llc?trk=top_nav_home> *[image: https://s3.amazonaws.com/images.wisestamp.com/icons/twitter.png]* <http://twitter.com/ApetanLLC> [image: e verify] *Disclaimer*: We respect your Online Privacy. This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line at [email protected] and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e mails to you. We are sorry for the inconvenience.
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