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Senior Regulatory Affairs Specialist - Largo, United States - CONMED Corporation
Description
Purpose:
The Senior Regulatory Affairs Specialist will provide regulatory support for New Product, Sustaining Engineering, and/or Operations project teams by identifying the appropriate domestic and international regulatory requirements and developing a regulatory strategy for global product commercialization.
Duties and Responsibilities:
Represent the Regulatory organization in either cross functional design teams or ancillary support to develop and implement regulatory strategies and carry out associated output responsibilities.
Review and/or approve proposed design changes and ECOs to assess regulatory impact.
Oversee documentation preparation on various projects.
Interface with other CONMED business units/affiliates/distributors as assigned.
Perform other related duties and special projects as required by management.
Required Qualifications:
Minimum of 3 years in a regulatory affairs position that includes proof of hands-on submission experience for US and/or EU
Bachelor of Science degree in a science, technical, or related field required or equivalent.
Preferred Qualifications:
Knowledge of domestic and international medical device standards and regulations.
Knowledge of domestic and international labeling requirements.
Ability to execute assignments independently as assigned.
Must possess strong organizational skills.
Must possess strong written and verbal communication skills.
Must possess demonstrated ability to handle multiple priorities simultaneously.
Proficient on Microsoft Office products.
0-20% travel.
This position is not eligible for employer-based visa sponsorship.
Disclosure as required by applicable law, the annual salary range for this position is 60,000 to 95,000. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED's good faith belief at the time of this posting.
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 option #3.
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