Technical File Reviewer (Remote) Job at Insight Global, Rutherford, NJ

U01OTmg0L010TVBtNSsyVDRrMGRxRzlRZEE9PQ==
  • Insight Global
  • Rutherford, NJ

Job Description

Insight Global is seeking a Technical File Reviewer (Product Assessor) to join the business assurance group for one of our Inspection and Certification clients. This position will be responsible for conducting comprehensive assessments of soft tissue medical devices through reviewing technical files. During this process, this person will focus heavily on the electronics of each product and ensure that technical files adhere to requirements outlined in European Medical Device Directive and Medical Device Regulation for Class I/ IIa /IIb and/or Class III medical devices. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: . Required Skills & Experience Bachelors degree in Science or Engineering (preferably electrical engineering) 5+ years of experience in designing, manufacturing, or testing medical devices Knowledge of European medical device standards and regulations (93/42/EEC, 2017/745) Experience with medical devices incorporating software / utilizing software / controlled by software (MDS 1009) Excellent communication skills through electronic mediums Nice to Have Skills & Experience Experience conducting product assessments for another certification organization Previous experience with soft tissue products Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law. Insight Global

Job Tags

Similar Jobs

Tandym Group

Medical Assistant - (OBGYN) Job at Tandym Group

 ...health services organization is currently seeking a certified Medical Assistant (MA) to join one of their facilities in Brooklyn. About...  ..., clinical, and documentation skills. Seniority Level ~ Entry level Employment Type ~ Full-time Job Function... 

Msaid Gmbh

Frontend Developer (fulltime, m/w/d) Remote (Greece) Job at Msaid Gmbh

 ...Kavala-based) to expand our SaaS platform team. This remote position is open to candidates based in Greece, as it is offered under a Greek work contract, including all social benefits as mandated by Greek labor laws. Drive the development of the VueJS frontend for the... 

Capital One

Lead Software Engineer, Back End/Full Stack (Intelligent Foundations & Experiences) Job at Capital One

 ...Job Description Lead Software Engineer, Back End/Full Stack (Intelligent Foundations...  ...diverse technology projects and a team of developers with deep experience in distributed microservices...  ...or non-exempt status, and management level. This role is expected to accept... 

MSI Inc.

Entry Level Communications Assistant Job at MSI Inc.

 ...We are currently seeking a proactive and detail-oriented Marketing Communications Assistant to support our event marketing initiatives. This role plays a key part in delivering clear, engaging communications and supporting the successful execution of live events. The... 

ABB

Internal Communications Intern- Summer 2026 Job at ABB

 ...what runs the world. This Position reports to: Country Communications Manager As an intern, you will have the opportunity to gain...  ...the United States are not eligible for company-sponsored medical benefits, 401(k) contributions, or paid time off. The hourly...