Medical Device, Quality/Risk Management, Research & Development, Submission & Registration
4 Year Degree
As a senior regulatory affairs specialist, you 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. At CONMED, we have a broad portfolio of interesting products and a global reach. If you are interested in learning new things and expanding your scope of responsibility, you'll find many exciting new challenges in this role.
We are seeking a collaborative leader who is an expert in regulatory affairs and design control, and also has demonstrates business acumen and confidence in exploring creative options with cross-functional teams. If you have great listening and critical thinking skills, you will be able to exercise independent judgement as you anticipate issues, assess risks and determine the optimal regulatory pathway as a respected member of our design teams.
You will ensure product registrations are completed in accordance with project schedules. You should have exceptional writing skills, with a proven track record of independently preparing and submitting documentation to domestic and/or international regulatory authorities. In this role, you may also oversee this process for more junior level regulatory professionals. This position also includes communicating with regulatory agencies, as needed, as well as researching, preparing, and presenting information for global corporate audiences and senior management. In addition to new product development, you will assess the domestic and/or international regulatory impact for process improvement and cost savings initiatives.
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 or supervise 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, providing guidance and mentoring to junior level RA professionals.
Assist in reporting and presentation compilation for senior management.
Interfaces with other ConMed business units/affiliates/distributors as assigned.
Perform other related duties and special projects as required by management.
Minimum of five to seven years in a regulatory affairs position that includes proof of hands-on submission experience is required.
Bachelor of Science degree in a science, technical, or related field required or equivalent.
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. Multi-Lingual candidate preferred.
Employer will assist with relocation costs.
Additional Salary Information: Exceptional healthcare and 401k match. Tuition assistance.
Internal Number: 5023
About CONMED Corporation
We are a global medical technology company that specializes in the development and sale of surgical and patient monitoring products and services that allow our physician customers to deliver high quality care and as a result, enhanced clinical outcomes for their patients.
With products that are recognized as technological leaders by the specialties they serve, caregivers within the Orthopedic, Sports Medicine, General Surgery, Gynecology, Gastroenterology, Pulmonology, and Anesthesiology markets have come to value the CONMED name across the world.
Our broad portfolio focuses on the needs and wants of specific specialties while coming together at the point of care delivery to offer our customers the power of choice and the power of convenience.