What are the responsibilities and job description for the Regulatory Affairs Admin II position at CONMED Corporation?
The Regulatory Affairs Admin plays an integral role within the RA team by ensuring the accurate preparation and maintenance of relevant material. This role will assist in the preparation of Technical Files/Product Files and assist RA personnel to prepare and maintain required documentation related to new and existing products.
This is a REMOTE Opportunity.
Key Duties and Responsibilities:
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.
Required Qualifications:
Associate degree in business or related field
6-12 months' in an administrative or clerical role
Preferred Qualifications:
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
Disclosure as required by applicable law, the hourly pay rate range for this position is 19.00 to 29.00. The actual compensation may vary based on geographic location, work experience, education and skill level. The hourly pay rate range is CONMED's good faith belief at the time of this posting.
0-20% travel
This position is not eligible for employer-based sponsorship
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- 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
Know someone at CONMED?
Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.
