NeuMoDx Molecular Inc. (“NMDX”) designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. In addition to focusing design and development efforts on tests to detect Sexually Transmitted and Infectious Diseases, NMDX has developed and will commercialize a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDTs) for use with the NMDX Molecular Systems to detect and amplify DNA and RNA targets.
Regulatory Affairs Specialist
NeuMoDx is seeking a a Regulatory Affairs Specialist responsible for the preparation of regulatory submissions and documentation required to market new or modified in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including analytical and clinical studies, addresses applicable regulatory requirements as well as meets the objectives of the business.
- Interpret, understand, and apply U.S. and international in vitro diagnostic device (IVD) regulatory requirements, statutes, regulations, policies and guidance documents to various projects.
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic area and discipline relevant to assigned projects.
- Assist in 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.
- Maintain product technical files for ongoing activities related to compliance with global directives and regulations.
- 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.
- Assist in the regulatory review of labels, labeling, advertising and promotional materials.
- Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to U.S. and international regulatory requirements.
- Assist in the creation of operating procedures and policy guidelines.
- May perform other duties as required or assigned.
Experience and Qualifications:
- Experience with regulatory submissions including 510(k) and PMA submissions.Bachelor’s degree (minimum) required in a science, engineering or related technical field; advanced degree preferred. Regulatory affairs certification preferred.
- Minimum 5 years of experience in regulatory affairs; IVD experience highly desired.
- 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 and have a good driving record.
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.
For consideration, please submit CV & salary requirements to email@example.com and mention the job description in the subject. No phone calls please. Only qualified candidates will be contacted.