Global Regulatory Affairs Internship -Department: -QA/RA -Location: -Lexington, MA -2018 Summer Intern:Global Regulatory Affairs Lexington, MA COMPANY OVERVIEW: OmniGuide, Inc. is a leader in the development of precision energy solutions that improve patients lives. By leveraging our proprietary flexible CO2 laser technology, our products enhance surgical accuracy, access and control for minimally invasive surgery, laparoscopy and robotic-assisted surgery. We are committed to operating under a quality system in accordance with domestic and worldwide requirements for medical device companies and are accountable to drive continuous improvement in the work we perform. RESPONSIBILITIES: The Global Regulatory Affairs Intern will be responsible for assisting in generating and maintaining all the regulatory registration applications and approvals for Distributors as well as direct filings (both US & OUS) as predicated to allow the company to market its products globally. They will help prepare submissions to obtain and maintain global regulatory approvals for clinical research and commercial distribution of OmniGuide products. Essential tasks include, but are not limited to: With minimal supervision, coordinate and prepare submission packages for regulatory or legal agencies, including but not limited to: -Generate Letters of Authorization/Power of Attorney for signature by CEO -Obtain Notarization of Legal Documents -Legalization of Document Packages by local, State and National Authorities and Country Embassy/Consulate Staff -Coordinate Apostile, legalization and appending applicable country embassy authentications to document packages with service provider -Submission of Legalization Package to the proper National Authorities -Assemble and package engineering documentation, product descriptions, product labeling and advertising as required by each National Authorities. -Receive and file accordingly country specific approvals and licenses -Maintain accurate and complete records of each country/distributor approval, registration and legal documents as required -Assist in the preparation of routine regulatory department reports and other required documentation. -Respond to Country Specific information requests -Track, prepare and submit renewal/reregistration documentation as required by National Authorities QUALIFICATIONS -Candidates seeking a BS/MS degree in Regulatory Affairs are preferred, though we may be willing to consider other relevant degrees -Candidates must be in good standing at their university and/or field of study -Superior organizational skills required -Ability to manage multiple projects -Excellent written and oral communication, technical writing and editing skills -Ability to interact and maintain close relations with various departments including Sales, Customer Service and Engineering and outside Agencies and Authorities -Proficiency with Microsoft Office (Word, Excel, PowerPoint, Project, etc.) and Adobe Acrobat -Work with minimal supervision Reports to Vice President, QA/RA OmniGuide provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.