Neumodx Molecular, Inc.
Location
Ann Arbor, MI | United States
Job description
NeuMoDx Molecular Inc. is an innovative medical device company dedicated to developing vastly superior solutions for molecular diagnostic (MDx) testing in hospital and clinical reference laboratory settings. NeuMoDx is seeking a Sr. / Regulatory Labeling Specialist responsible for all facets of product labeling, e-labeling, website and promotional materials, etc. This responsibility entails interpreting the medical device / in vitro diagnostic (IVD) regulations for product labeling, as well as the execution, management and tracking of requirements for all products, package inserts, labels and related items for the US as well as foreign markets.
Responsibilities:
Lead the regulatory review of all labeling based on the various domestic and international requirements – including product labels, instructions for use, e-labeling, website, advertising, and promotional materials
Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance for changes requiring regulatory agency approval, as pertains to U.S. and international regulatory requirements
Interpret, understand, and apply U.S. and international in vitro diagnostic (IVD) device regulatory requirements, statutes, regulations, policies and guidance documents to various projects
Manage the revision history of all product labeling and coordinate the translation of approved product labeling into the required languages of international markets while upholding all applicable requirements
Maintain product technical files for ongoing activities related to compliance with global directives and regulations.
Create and manage control of UDI requirements and listings.
Assist with the submission activities for a variety of in vitro diagnostic device regulatory approvals including CE mark, U.S. premarket approvals (PMAs), U.S. premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
Contribute to the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market surveillance activities in support of U.S. FDA and international regulatory submissions, as required
Lead the effort for creation of operating procedures and policy guidelines regarding US and CE-IVD labeling requirements
Perform other duties as required or assigned
Experience and Qualifications:
Bachelor’s degree required in a science, engineering or related technical field; advanced degree preferred.
Minimum 5 years of experience in regulatory labeling; IVD experience highly desired
Experience in medical device labeling, including Instructions For Use (IFUs), preferably IVD
Experience with CE Mark Technical File and Design Dossier submissions for Medical Devices, preferably for In Vitro Diagnostic Systems
Regulatory Affairs Certificate (RAC) preferred
Strong organizational skills, effective writing skills and meticulous attention to detail
Ability to work in a fast-paced/entrepreneurial team environment
High degree of initiative with the ability to work independently with minimal supervision
Ability to prepare and present concise information to groups
Experience working effectively in a cross-functional team setting
Ability to comprehend principles of engineering, physiology and medical device use
Capacity to plan and organize work while remaining flexible enough to handle multiple priorities
Candidates must be able to work in the U.S. on an unrestricted basis.
NMDx offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, and medical/dental plans. In-house position; relocation package not available.
For consideration, please submit resume along with salary requirements to [email protected] and mention the job description in the subject.
Job tags
Salary
