As the company continues to grow, we are seeking a Senior Regulatory Affairs Associate that will contribute to Clinical Laboratories (CL) base business support, and with oversight, will interact with International Regulatory Affairs and the US FDA to create regulatory plans and submissions for modified and/ or new products in development. This position is located in Rochester, NY
- Support base business activities, such as Annual reports for Class 3 assays, Ad/ Promo reviews, Labeling reviews, and change management reviews for regulatory submission impact. Support regulatory colleagues to prepare their submissions by performing tasks such as completing FDA forms, performing editorial reviews of submission content, and preparing eCopies.
- Identify and/ or support process improvement projects to streamline current activities and increase department efficiencies.
- With oversight, provide regulatory support to Clin Labs project teams in terms of submission requirements, timing, and risks. Interact with US FDA and/ or International regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters. Prepare submissions to meet regulatory agency expectations.
- Development goals, such as webinars, review FDA website and articles, read journals, attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs.
- Support regulatory inspections, as needed
- Support activities for IVDR preparation, as needed, in terms of claims support refresh, labeling updates
- A minimum of a Bachelor’s degree in a scientific or related discipline is required.
- Five years’ experience or equivalent in terms of education and/or experience developing and executing regulatory strategies for medical devices is required. In Vitro Diagnostic medical device experience is preferred.
- Working knowledge of US, EU, and International regulations, Quality System Regulations, and guidance’s’ for medical devices, preferably IVDs, is required.
- An understanding of product development is preferred.
- Excellent interpersonal skills, teamwork, decision-making/ prioritization and verbal/ written communication skills are required.
- Organizational skills and multi-tasking ability to manage multiple tasks, projects, priorities simultaneously are required.
- Ability to work with business partners across geographies and time zones is critical.