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Senior Regulatory Affairs Specialist

Company

CooperCompanies

Location

Sweden, Sweden

Type

Full time

Job Summary

The Senior Regulatory Affairs Specialist will provide Regulatory support and direction to products from concept to launch.The Sr. RA Specialist follows the regulatory strategy for assigned corporate projects.Assists in creating, developing, and implementing global regulatory affairs procedures for marketed products and to ensure company’s regulatory compliance status. The Senior Regulatory Affairs Specialist fulfils some of the responsibilities of the Person Responsible for Regulatory Compliance, per Article 15 (3) of the MDR, in a shared capacity

Essential Functions & Accountabilities:

Registration Activity

  • Prepares, compiles, and submits regulatory documents for the registration of current and new products in assigned markets.
  • Maintains submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
  • Monitors pending submissions t...
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