- File necessary applications and handle all government interactions pertaining to the regulation process for products requiring governmental approval.
- Author and submit PMA supplements, including 30-day Notice, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
- Review and approve engineering study protocols/reports and validation study protocols/reports.
- Review and approve manufacturing changes for Class III implantable medical devices.
- Support the transfer of Legal Manufacturers for Third Party Manufactured products from the USA to Europe and transition products from the EU IVDD to the EU IVDR.
- Review and approve Tech File and PMS documents.
- Provide Design plan Reg assessments.
- Respond to questions from internal and external stakeholders.
- Advanced degree preferred.
- 5-8 years of direct experience in the field.
- Recent experience with Class III implantable medical devices.
- Proven successful track record of authoring, submission, and approval of Class III implantable PMA supplements.
- Knowledge of FDA PMA guidance documents and CFR regulations.
- Experience in IVD Regulatory Affairs preferred.
- Project Management skills.
- 7-month contract with possibility to extend
- FT, M-F 40hr/week
- Pay Rate: $28-30/HR ($56-60K Annually)
- Remote job
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Regulatory Affairs Associate
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School of the Art Institute of Chicago Chicago, United StatesThe Art Institute of Chicago shares its singular collections with our city and the world. We collect, care for, and interpret works of art across time, cultures, geographies, and identities, centering the vision of artists and makers. We recognize that all art is made in a partic ...
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Found in: beBee S2 US - 5 days ago
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Regulatory Affairs Associate - Lake Forest, United States - GForce Life Sciences
Description
Regulatory Affairs Associate – Abbott Park, IL
Must be able to work on a W2
Job Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Key Responsibilities:
Qualifications:
Term & Start
