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Regulatory Affairs Specialist I

  • Job reference: 933659
  • Location: Chaska, Minnesota
  • Salary: USD264 - USD288 per day
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 22/01/2021

We at Orion Group are currently recruiting a Regulatory Affairs Specialist I on behalf of one of our Multinational Medical Device Clients to work on a 5-month contract.

The Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Company regulatory programs.

RESPONSIBILITIES:

  • Administration of the company's complaint management program for compliance to corporate requirements
  • Assist in the planning and implementing pre-market registration, reporting and compliance activities in accordance with the business plans.
  • Assists in the implementation of global regulatory compliance programs for product corrective action and/or adverse event reporting.
  • Assist in the preparation of premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.

QUALIFICATIONS:

  • Bachelors degree in field with 2+ years exp. OR
  • Masters degree in field with 1+ years exp.
  • IVD experience strongly desired.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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