Attorney in Cambridge, MA

In-House

Cambridge, MA

Attorney in Cambridge, MA

Attorney

Min 5 yrs required

No

Associate Domain Architect
The candidate will make transformative and innovative contributions to global regulatory affairs and quality systems operations for medtech industry customers worldwide. Lead and perform professional services and solutions development duties in global RA/QA and related systems development, including supervisory responsibilities for analyst and development functions. Demonstrate a mature, professional attitude and responsive, high-quality teamwork. Achieve all requisite core and professional competencies, demonstrating subject mastery on core certifications (Microsoft MOS and MTA, foreign language, and typing) and professional certifications (RAPS RAC (US, EU, and Global), and ASQ CQPA and CBA). Ongoing professional development and job performance sufficient to qualify for the position of Solution Architect within 12 months of employment. Should have 5 years successful medtech industry experience. Must have Undergraduate BS or equivalent degree in electrical, chemical, or mechanical engineering. Graduate JD or equivalent degree in law from a leading US law school is required. Must possess an active license to practice law. Most possess or be eligible to sit for a foreign language competency certification in one of the following: German; Korean; Japanese; or Chinese. Must be able to demonstrate a strong working knowledge of applicable medtech Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practices (GCP), regulations, standards, and product development processes. Certifications in RA, QA, and/or Microsoft information technology a plus.