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Job Details

Regulatory Affairs Specialist

Company name
Pinpoint Pharma

Salary
43

Location
Lake Zurich, IL

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Job Description
Job Title:  Regulatory Affairs Specialist \r\rJob Overview:  The Regulatory Affairs Specialist is responsible for supporting compliance to global regulations, listings and licenses. The individual will be responsible for the development and revision of new labels, instructions for use, and other materials that are under the regulatory control and may assist in compiling and submitting regulatory documents according to requirements and will provide support for all regulatory compliance activities including labeling and advertising, import and export and field corrections. \r\r\rEssential Duties and Responsibilities: \r\r Support regulatory submissions of Regulatory Affairs for assigned new and/or modified products as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance.\r Review labeling and promotional materials for assigned products for regulatory compliance, in particular ensuring labels, instruction for use, and promotional materials conform to product clearances, approvals and Licenses.\r Assess and document impact of proposed product changes on regulatory filings.\r Support the management of Safety Data Sheets (SDS).\r Maintain regulatory affairs product files to support compliance with requirements and standards. May support the generation and update of technical files and declarations of conformity.\r May assist with regulatory audits from partners and external regulatory agencies.\r Draft and update regulatory affairs procedures.\r Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company and sector.\r\r\r

Job Requirements
Requirements:\r\r Minimum Bachelor’s Degree in Science (Chemistry, Biology, Biochemistry, Microbiology, etc.).\r Minimum of 3 years previous experience in regulatory affairs of medical device. \r Strong understanding of medical device regulations.\r IVD experience is plus.\r

Company info

Pinpoint Pharma

Company Profile

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