Senior Regulatory Affairs Specialist

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.

They will ensure product registrations are completed in accordance with project schedules. They will assess the domestic and / or international regulatory impact for process improvement and cost savings initiatives.

In this position, they will prepare documentation to domestic and / or international regulatory authorities. They will communicate with regulatory agencies, as needed.

They will work independently without direct supervision. They will perform other regulatory duties as assigned.

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.
• Prepare and assist in the preparation of global regulatory files / submissions for product registrations as assigned.
• 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 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

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