Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist

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:

  1. Supporting medical device products with regards to regulatory changes and quality improvement activities.
  2. Establish and maintain appropriate systems to ensure regulatory compliance consistent with state, federal and international product requirements.
  3. Complete product applications for the US, Canada, South America, Europe and other countries around the world.
  4. Provides customer support on regulatory issues.
  5. Review change requests/engineering changes and provides RA strategy for US and EU assessments.

Requirements:

  1. Bachelor’s degree in a scientific field.
  2. Minimum two years of regulatory experience in the Medical Device industry.
  3. ED and MDE labeling experience.
  4. Clear knowledge of medical device regulations and standards (FDA, MDR, ISO 9001 and ISO 13485).
  5. RoHS/REACH experience is preferred.
  6. Product registration experience and knowledge on a worldwide basis.

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