The Regulatory Affairs Specialist III is responsible for providing technical support to the Regulatory Affairs Manager in order to remain in compliance with FDA, and all other U.S. and international regulatory requirements. The Regulatory Affairs Associate will prepare US and International regulatory submissions, including 510(k)’s, for LSMS products, including IVD as directed by the Regulatory Affairs Manager.
- Writes, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including International Authorities.
- Prepares international documents, including Technical Files.
- Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
- As directed reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments.
- Provides regulatory advice to project teams.
- When required evaluates proposed product modifications for Regulatory impact on a world-wide basis.
- Completes Regulatory Assessments.
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies’ questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Develops timelines for submissions under the direction of the Regulatory Affairs Manager.
- Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
- Keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news, and will assist in the development of best practices for Regulatory Affairs processes.
- Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Reviews regulatory authorization related to ongoing product design changes and field action investigations as directed by the Regulatory Affairs Manager.
- A minimum of a Bachelor’s Degree is required, preferably in a scientific discipline.
- Approximate experience of 4 to 6 years in the medical device and/or pharmaceutical industry OR an Advanced Degree and a minimum of 3 years of regulatory experience in the medical device and/or pharmaceutical industry is required. LCMS or Clinical Chemistry experience is preferred.
- Solid knowledge of US FDA regulations and review processes are required.
- Practical experience in a medical device Regulatory Environment, preparing US submissions and a successful track record are required.
- Technical Files experience is required.
- Experience interacting with US FDA is required.
- Experience in Asia/Pacific and South American regulations and submissions is preferred.
- Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
- Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
- Being detail-oriented, while having the ability to handle multiple ongoing projects/tasks is required.