In this exciting role, you’ll have an opportunity to support the development of innovative new products. 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. As a regulatory affairs specialist, you will provide regulatory input for new product and sustaining engineering project teams for the successful global commercialization of products. You will identify both domestic and international regulatory requirements early in product life cycles and coordinate the product registrations to meet company milestones and initiatives. You will prepare and maintain registrations of CONMED products, and also assess and provide feedback on regulatory impact of process improvement and cost saving initiatives. Duties and Responsibilities:
Represent the Regulatory organization on cross functional teams to develop and implement regulatory strategies and carry out associated team output responsibilities.
Prepare global regulatory files/submissions for product registration as assigned.
Review and approve proposed design changes and ECOs to assess regulatory impact.
Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
Provide regulatory support for on-going global product registrations as assigned.
Provide timely review and approval of product labeling for regulatory compliance.
Interfaces with other ConMed business units/affiliates/distributors as assigned.
Perform other related duties and special projects as required by management. Requirements:
Minimum three to five years in a regulatory, quality or similar position.
Bachelor’s degree in science, engineering or related field required. Additional hands on regulatory affairs experience may substitute for educational requirement.
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.
CONMED Corporation is a progressive, global medical device company. Through thoughtful leadership, innovation and team work, we are changing the future of medicine. Our 3,500 employees worldwide make meaningful contributions, positively impact the business, and advance in their careers as our company and product portfolio grows.
We are a leader in Orthopedics, General Surgery, Gynecology, Gastroenterology, Pulmonology, and Anesthesiology and our employees enjoy challenging and diverse job opportunities across these varied specializations. We are headquartered in upstate New York with additional domestic facilities in FL, CA, MA, CO, and GA. We have an international presence in more than 20 locations throughout Europe, Australia, Latin America, Asia, North America, and the Middle East.
CONMED offers 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) — company match dollar for dollar up to 7%
Employee stock purchase plan — allows stock purchases at discounted price
Tuition assistance for undergraduate and graduate level courses
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, genetic information, disability, or veteran status.
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Source: http://www.indeed.com/viewjob?t=Regulatory+Affair+Specialist&c=Conmed&l=Westborough,+MA&jk=142be6bfd1067369&rtk=1cuop2c9rg2q6801&from=rss
