Assistant Director, Regulatory Medical Device

Company Name:
Systems Technology International(STI), Inc
Location :Whippany, NJ
Divisions include
Specialty Pharmaceuticals, Medical Care, Consumer Care and Animal Health. At this top tier Pharma company you have the opportunity to be part of a culture where they value the passion of their
employees to innovate and give them the power to change.
The company is expanding and looking for an Assistant Director for their Class III /PMA /Medical Device High Profile Trials
Need PMA, IDE and Class III experience - this experience IS required
The Assistant Director Regulatory Medical Devices is responsible for providing input into the development, alignment, and implementation of technical regulatory strategies to ensure earliest submissions and first cycle approvals for assigned development projects on a global basis. The Incumbent will represent GRA on project development teams as it pertains to the technical regulatory aspects of the project. This includes, but is not limited to, ensuring all relevant FDA device guidelines and standards are adhered to. The Incumbent will also ensure close alignment of the development team with Product Supply and Quality Assurance and serve as the CMC/device interface on all regulatory matters involving Companys device portfolio partners. In addition to new product development activities, the candidate will also be responsible for overseeing the post approval maintenance activities such as change controls, annual reports (IDE/PMA), supplements, amendments and DHF maintenance activities pursuant to 21 CFR 820, ISO 9001/13485.
Provides guidance and oversight to Project Teams involving technical regulatory matters in support of new development and maintenance work for Companys medical device product portfolio.
Coordinate/review supportive data to ensure high quality and technically correct dossiers in accord to established timelines.
Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization on medical device matters.
Implements local and global regulatory project goals from development through life cycle. Provides technical regulatory support for the development of multiple project goals on a local and global
level. Represents Global Regulatory Affairs on global Project Teams.
Ensure the accuracy, scientific consistency, and compliance to local and global HA regulations and completeness of submission data.
Maintain up-to-date knowledge on international and domestic regulatory requirements and their relevance to Companys medical device portfolio.
Assist, as needed, with preparations for meetings and teleconferences with local and global HA officials.
Assist, as needed, with regulatory due diligence activities on potential in-licensing opportunities
BS degree in life sciences or engineering with at least 8 years of pharmaceutical and or medical device experience, of which at least 5 years includes hands-on medical device experience preferably with class III devices, or
Advanced degree in life sciences or engineering with at least 5 years pharmaceutical and or medical device experience, of which at least 3 years includes hands-on medical device, experience preferably with class IIII device.
Extensive knowledge of US and global regulations as it pertains to registration and maintenance of class III medical devices. Demonstrated interactions with local and global health authorities.
He/she must be able to work focused and target oriented in a complex scientific / technical environment. The incumbent will be required to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure. In many cases competing objectives will have to be harmonized and prioritized to achieve overall objectives.
The ability to work within a global team framework and a multicultural environment is essential. He/she must have well developed project management skills, including interpersonal skills. Good communication skills, verbal and written, are required.
As necessary, the Incumbent may called upon to assume specific leadership roles and direct subordinates on specific work-related projects.
A clear understanding of cultural and business needs while working in a global project team environment
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