Regulatory Affairs Specialist
Posted on: May 10, 2019
The Regulatory Affairs Specialist provides regulatory input for new
product and sustaining engineering project teams; developing a
regulatory strategy for global commercialization of products. The
specialist should be capable of identifying both domestic and
international regulatory requirements early in product life cycles
and coordinating the product registrations to meet company
milestones and initiatives. Prepares and maintains registrations of
products marketed by ConMed business areas as assigned. 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
* 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
* Interfaces with other ConMed business
units/affiliates/distributors as assigned.
* Perform other related duties and special projects as required by
* Minimum three to five years in a regulatory, quality or similar
* 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, strong written and verbal
communication skills. Must possess demonstrated ability to handle
multiple priorities simultaneously.
* 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
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
* CONMED offers competitive compensation
* Excellent healthcare including medical, dental, vision and
* 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
* Tuition assistance for undergraduate and graduate level
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, or
Keywords: CONMED, Largo , Regulatory Affairs Specialist, Other , Largo, Florida
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