Regulatory Affairs Senior Specialist - Regulatory Intelligence

Posted: Thursday, 07 August 2025
Valid Thru: Saturday, 06 September 2025
Index Requested on: 08/07/2025 14:16:44
Indexed on: 08/07/2025 14:16:44

Location: Victor, NY, 14564, US

Industry: Advertising and Public Relations
Occupational Category: 13-0000.00 - Business and Financial Operations
Type of Employment: FULL_TIME

CooperVision, Inc. is hiring!

Description:

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.

Responsibilities:

Please review the job description.

Educational requirements:

  • high school

Desired Skills:

Please see the job description for required or recommended skills.

Benefits:

Please see the job description for benefits.

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