Regulatory Manager - (Job Number: 0714035)

Regulatory Manager - (Job Number: 0714035) DescriptionVeridex, LLC, a member of Johnson && Johnson's Family of Companies, is recruiting for a Regulatory Manager located in Warren, NJ. Veridex, LLC provides cancer diagnostic products that will enable earlier disease detection and more accurate staging, monitoring and therapeutic management of cancer patients. The company is initially commercializing two complementary pr oduct lines: CELLSEARCH assays that identify, enumerate and characterize circulating tumor cells directly from a single tube of blood; and GENESEARCH assays that use molecular technologies to diagnose, stage and more accurately characterize tumors. The Regulatory Manager will provide guidance, leadership, and drafts and manages the preparation of regulatory submissions for assigned products consistent with established regulatory policies and regulations. This includes the review of information for accuracy, soundness, and regulatory appropriateness before actual submission to the regulatory agency. The Regulatory Agency will be the FDA, technical file for CE mark, and/or other foreign countries. The regulatory manager interprets Regulatory Agency policies, procedures, and regulations on how they change and/or impact Veridex product approvals and submissions. Reviews, drafts, and approves SOPs, specifications, clinical protocols, labeling and advertising for assigned product responsibilities. Ensures compliance with FDA regulations. Level of individuals with whom major interactions will take place: Director, Professional, Manager, R&&D Scientists. Percentage of Time Spent Traveling: 0-25% of the time as needed by the business/products. A minimum of a Bachelors degree in scientific discipline required, a Masters degree is preferred. At least 5 years of comprehensive regulatory experience required. Supervisory experience a plus. Previous project management experience is a plus. Excellent written, verbal and listening communication and negotiation skills are required. Working knowledge of FDA regulations, Quality System Regulations is required. Knowledge of IVD Directive for in vitro medical devices is a plus. Experience with Rest of World submissions is a plus. Ability to manage multiple projects and changing priorities is required. Technical knowledge of molecular and/or cellular products and processes is preferred. Demonstrated ability to work effectively in both cross-functional teams and independently is required. Basic work processing skills and understanding is required, as is the ability to handle stress and work under pressure. Must be able to read large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes. Experience managing regulatory affairs for an IVD company and experience filing 510(k)s and/or PMA submissions is strongly preferred. Experience working with the FDA is required. If you want to explore the many small-company environments behind the big-company impact of the Johnson && Johnson Family of Companies, bid on this position today! Apply Now