ERT Senior Regulatory Affairs Specialist in Boston, Massachusetts
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.
The Boston office is looking for a Senior Regulatory Affairs Specialist who will work closely within ERT departments to establish and ensure compliance with the quality system and ensure regulatory compliance in key markets.
ESSENTIAL 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.
Hours: Mon-Fri, 9-5
External Company Name: eResearch Technology