Regulatory Affairs Administrator I
Job Description:
• Perform preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
• Compile all materials required in submissions, license renewal and annual registrations.
• Prepare the necessary copies of international documents, CE Certificates, CFG's and other regulatory documents.
• Assist in updating and maintaining Technical files for submission to the Notified Body for changes in manufacturing and/or design.
• Maintain the Global RA database for the Corporation.
• Provide administrative support to RA Department personnel.
• Complete other tasks assigned by management as needed.
Requirements:
• Associate degree in business, science, or related field
• 6-12 months’ in an administrative or clerical role
• Experience working with technical specifications and highly detailed paperwork
• Preferred strong computer skills
• Must possess strong organization skills
• Must possess strong written and verbal communication skills
• Demonstrated ability to handle multiple priorities simultaneously
Benefits:
• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses
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• Perform preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
• Compile all materials required in submissions, license renewal and annual registrations.
• Prepare the necessary copies of international documents, CE Certificates, CFG's and other regulatory documents.
• Assist in updating and maintaining Technical files for submission to the Notified Body for changes in manufacturing and/or design.
• Maintain the Global RA database for the Corporation.
• Provide administrative support to RA Department personnel.
• Complete other tasks assigned by management as needed.
Requirements:
• Associate degree in business, science, or related field
• 6-12 months’ in an administrative or clerical role
• Experience working with technical specifications and highly detailed paperwork
• Preferred strong computer skills
• Must possess strong organization skills
• Must possess strong written and verbal communication skills
• Demonstrated ability to handle multiple priorities simultaneously
Benefits:
• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses
Apply tot his job
Apply To this Job