Regulatory Affairs

  • location: Pewaukee, WI
  • type: Contract
  • salary: $86 - $121.42 per hour
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job description

Regulatory Affairs

Contract position: A Regulatory Affairs Consultant is needed for a leader in electronics, healthcare and lighting in the Pewaukee, WI area. This position will work with other teams to ensure the regulatory requirements and globally harmonized standards are understood and represented in ways of working during product design, in change control and risk management, as well as manufacturing processes. No per diem available. No travel anticipated. 1st shift.

Responsibilities for the Regulatory Affairs
  • Plan, generate, and coordinate regulatory submissions for product/solution licensing approvals in the EU market.
  • Support development of the regulatory plan, guidance on risk assessment for CE marking ad clinical evaluations.
  • Work closely with other regulatory and clinical professionals to ensure all product and clinical information is adequately and correctly represented.
Requirements for the Regulatory Affairs

  • At least 2 years of experience in international and domestic regulatory submissions. Must have least 2 years of experience writing and assembling technical files or design dossiers.
  • Prefer experience in a legal or regulatory discipline as related to medical device products.
Benefits

  • 401k
  • Healthcare
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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