Company: Emonics, LLC
Posted on: January 27, 2023
Job Description: Responsibilities
- Candidate must have at least 3-5 years of QARA experience from
Medical Devices company.
- Should have knowledge of regulation of Medical Devices for US
FDA and Europe MDR.
- Should be abreast with the upcoming regulatory changes into
medical devices industry.
- Assist in the development of regulatory strategy and update
strategy based upon regulatory changes.
- Understand, investigate, and evaluate regulatory
history/background of class, in order to assess regulatory
- Lead and executes EUMDR Transition projects (such as
implementation of new/changed specific regulatory
- Reviews Change Orders and assess regulatory impact of product
changes per EUMDR and submissions per standard procedures.
- Supports post market regulatory compliance activities.
- Provides regulatory review of labeling, design changes, and
- Work with local RA teams, and develop International regulatory
strategies for product submissions.
- Work With cross functional team to lead & complete the
technical file for EUMDR.
- Work with offshore EUMDR Team.
- Ability to perform all assigned tasks, work independently, and
complete work on schedule.
- Ability to communicate effectively in multi-discipline, cross
cultural environment, and levels of organization.
- Strong problem-solving skills and efficient management of time
Keywords: Emonics, LLC, Miami , QARA Engineer, Engineering , Miami, Florida
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