Quantum Materials Corp. (fka QTMM)

[drugmanrx]

Companies that are ended do not look for NEW employees,

https://www.indeed.com/jobs?q=quantum%20material%20corp&l=austin%20texas&vjk=8c90c4b2860a1136

it’s already ended and it’s just dead money talking now.

and money being used to hire individuals to send products to government agencies for approval is far from dead money.

Regulatory Affairs Specialist
Quantum Materials Corp
3055 Hunter Rd, San Marcos, TX 78666
Full-time
Job details
Job Type
Full-time
Full Job Description
Job Summary:

The Regulatory Affairs Specialist will develop strategies and submissions for the companys products. Submissions will be globally based for our products. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements.
Essential Duties and Responsibilities:

Develop regulatory strategies for product development and launch of moderate-complexity projects.
Review and assess of change control activities for potential impact on current regulatory filings.
Ensures compliance with design controls and reviews design documentation to ensure that it follows the regulatory requirements.
Interpret existing regulations and guidance documents within regulatory department and on project teams.
Provides a regulatory expertise and oversight to design teams.
Identify risk factors and contingency planning for assigned projects.
Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
Interfaces as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products.
Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S.
Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.
Review and approve all labeling (product, advertising and promotional) verbiage.
Understand and communicate regulatory processes, guidelines and guidance documents and what they mean to the organization.
Apply understanding of the quality systems to job activities and projects.
Participate in training RA team members and others on compliance matters.
Brings Regulatory Affairs questions/issues to the attention of RA management.
Prepares monthly reports to RA management.
Adhere to and ensure the compliance of the companys Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
Other duties as assigned.