Regulatory Affairs Senior Specialist - Regulatory Intelligence

CooperVision seeks a Senior Regulatory Affairs Specialist - Regulatory Intelligence, in Victor, NY, to provide global regulatory intelligence expertise, regulatory affairs, pre-clinical, clinical, and commercial areas for investigational and marketed products.

The candidate will ensure that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the business.

The candidate will proactively monitor emerging external scientific and regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within portfolio areas.

The candidate will work with Global and Regional Regulatory Affairs to provide both routine and ad hoc requested information including implementing a commenting process on health authority guidance and directives.

100% remote work.

Requirements: Bachelor's degree in global clinical and pharmacovigilance regulations or related, plus 3 years of experience with sound knowledge of intelligence tools and methods, Agile PLM (product lifecycle management)/global RA database reporting functions, U.S.

regulations and guidance including FDA 21 CFR, MDSAP, ISO 13485, UKCA, MedDO, MDD, and MDR, regulations and guidance governing medical device in all phases of development.

The expected wage range for the position is $104,000- $135,000/year.

Please respond online to http://coopervision.com/careers - position #8352.