Regulatory Affairs Specialist
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Accentuate Staffing is currently seeking a Regulatory Affairs Specialist with a global medical device company. This full-time, six month contract opportunity offering highly competitive pay. The ideal candidate has a minimum of two years in Regulatory Affairs within the Medical Device industry and strong experience with both EU and MDR labeling.
Responsibilities:
- Supporting medical device products with regards to regulatory changes and quality improvement activities.
- Establish and maintain appropriate systems to ensure regulatory compliance consistent with state, federal and international product requirements.
- Complete product applications for the US, Canada, South America, Europe and other countries around the world.
- Provides customer support on regulatory issues.
- Review change requests/engineering changes and provides RA strategy for US and EU assessments.
Requirements:
- Bachelor’s degree in a scientific field.
- Minimum two years of regulatory experience in the Medical Device industry.
- ED and MDE labeling experience.
- Clear knowledge of medical device regulations and standards (FDA, MDR, ISO 9001 and ISO 13485).
- RoHS/REACH experience is preferred.
- Product registration experience and knowledge on a worldwide basis.
