technical file specialist

4 weeks ago

Minneapolis, United States Randstad Full time

technical file specialist. minneapolis , minnesota posted june 4, 2024 job details summary $75 - $83 per hour contract bachelor degree category computer and mathematical occupations reference1054317 job details job summary: Position Summary: The Senior Technical File Specialist will lead creation of EU MDR technical file, review product development materials and create regulatory submissions for the active implantable medical devices for the Neuromodulation Business Unit. The Senior Technical File Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements. The Senior Technical File Specialist will demonstrate commitment towards Organization's mission, vision, and pillars. General Responsibilities: Author, prepare and update Technical File for active implantable medical devices/systems in accordance with EU MDR requirements. Core-team regulatory member for new product development. Review regulatory strategies, deliverables, and timelines in collaboration with other team members. Responsible for regulatory authority queries on Technical file or submissions. Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents. Prepare regulatory submissions assigned (EU Technical file, notification of change, pre-submissions, IDE & IDE Supplements, etc.) Direct interface with the International Regulatory Agencies on assigned projects. Perform regulatory assessments of changes as part of the change management process. Work daily with a high level of integrity and promote a diverse and inclusive workplace culture in both people and thought leadership that is consistent with Organizational values. Skills and Experience: o Demonstrated experience in the development, writing and editing of regulatory/ clinical submissions (e.g. FDA PMA applications, IDE Progress Reports, EU technical files) o Understanding in US and EU regulatory requirements in medical device. o Demonstrated negotiation and conflict resolution skills. o Demonstrates ability to rapidly learn new therapeutic areas. location: Minneapolis, Minnesota job type: Contract salary: $75 - 83 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Position Summary: The Senior Technical File Specialist will lead creation of EU MDR technical file, review product development materials and create regulatory submissions for the active implantable medical devices for the Neuromodulation Business Unit. The Senior Technical File Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements. The Senior Technical File Specialist will demonstrate commitment towards Organization's mission, vision, and pillars. General Responsibilities: Author, prepare and update Technical File for active implantable medical devices/systems in accordance with EU MDR requirements. Core-team regulatory member for new product development. Review regulatory strategies, deliverables, and timelines in collaboration with other team members. Responsible for regulatory authority queries on Technical file or submissions. Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents. Prepare regulatory submissions assigned (EU Technical file, notification of change, pre-submissions, IDE & IDE Supplements, etc.) Direct interface with the International Regulatory Agencies on assigned projects. Perform regulatory assessments of changes as part of the change management process. Work daily with a high level of integrity and promote a diverse and inclusive workplace culture in both people and thought leadership that is consistent with Organizational values. qualifications: Experience level: Experienced Minimum 7 years of experience Education: Bachelors (required) skills: TechnicalEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).Applications accepted on ongoing basis until filled.

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