Vacancy Description
Job Title: Regulatory Affairs SpecialistJob Description
As a Regulatory Affairs Specialist, you will play a critical role in supporting regulatory compliance and quality systems for medical devices. You will assist in preparing, compiling, formatting, and submitting regulatory filings and maintain regulatory records and product registrations.
Responsibilities
+ Assist with the preparation, compilation, formatting, and submission of regulatory filings.
+ Maintain regulatory records, product registrations, declarations of conformity, and submission documentation.
+ Support regulatory agency correspondence and requests for additional information.
+ Participate in U.S. and international product registration and approval activities.
+ Support post-market regulatory requirements, including annual reports and regulatory updates.
+ Assess regulatory impact of product changes, manufacturing transfers, and process modifications.
As a Regulatory Affairs Specialist, you will play a critical role in supporting regulatory compliance and quality systems for medical devices. You will assist in preparing, compiling, formatting, and submitting regulatory filings and maintain regulatory records and product registrations.
Responsibilities
+ Assist with the preparation, compilation, formatting, and submission of regulatory filings.
+ Maintain regulatory records, product registrations, declarations of conformity, and submission documentation.
+ Support regulatory agency correspondence and requests for additional information.
+ Participate in U.S. and international product registration and approval activities.
+ Support post-market regulatory requirements, including annual reports and regulatory updates.
+ Assess regulatory impact of product changes, manufacturing transfers, and process modifications.
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