Senior Regulatory Affairs Specialist
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POST DATE 10/10/2017
END DATE 12/15/2017
JOB DESCRIPTIONESSENTIAL DUTIES AND RESPONSIBILITIES:
* Supports and provides regulatory expertise to assigned projects (eCOA, Respiratory and/or Cardiac Safety).
* Provides regulatory expertise concerning trade compliance, import and export requirements for mobile devices/handheld computers in key markets used in clinical trials.
* Monitor import/export regulatory changes and support advocacy efforts as needed.
* Ensuring of compliance of medical and non-medical devices/solutions using mobile devices/handheld computers with data protection, privacy rules and other applicable regulatory requirements (e.g. RED, FCC, IC, TELEC, GDPR (2016/679), HIPAA).
* Reviews and gap-analyses of technical documentation of ERTs solutions; consideration of current standards and regulations for medical and non-medical systems consisting of mobile devices used in clinical trials.
* Support of Corrective and Preventive actions for medical and non-medical devices and solutions related to import/export and certification status.
* Maintain regulatory and trade compliance procedures and work instructions to ensure compliance with local and international regulation.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
* Life Science, Technical or electrical engineer or equivalent
* At least 4 years of experience working with regulated devices
* Experience in a customs/global trade function and/or import/export of mobile devices/handheld computers for at least 3 years
* Working experience in wireless certification of mobile devices/handheld computers (e.g. FCC, IC, R&TTE/RED, TELEC) preferred
* Capability of understanding of medical and non-medical device systems/solutions
* Good trouble shooting capability and proactive communication skills
* Import/Export regulations for wireless devices
* R&TTE/RED, 47 CFR Part 15 and corresponding standards and guidelines
* 21 CFR Part 11, HIPAA Privacy Rule, GDPR (2016/679), Cybersecurity
* Good command of English, second language preferred
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.