Regulatory Affairs Specialist II
4 weeks ago
The Regulatory Affairs Specialist II supports new product development teams to ensure product requirements enable regulatory filings, ensuring compliance with international regulations. As a key member of the team, you will prepare and execute regulatory filings, including change management and support of outside vendors.
Key Responsibilities- Act as Regulatory Affairs lead for new product development projects, developing and maintaining regulatory strategies for new and modified products.
- Prepare and execute regulatory filings such as technical files and letters to file, conducting international registrations and providing input on product labels.
- Support setup and management of outside vendors, performing regulatory impact assessments for engineering changes and reviewing promotional materials.
Requirements:
- Bachelor's degree in Analytical Chemistry, Biochemistry, or Biomedical Engineering (Graduate education preferable).
- Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, knowledge of 21 CFR 820, ISO 13485, and European IVD regulations (IVDR preferred).
- Experience with preparation and execution of regulatory filings for US & EU regulatory approval.
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