* This role includes a full relocation package!
How will you make an impact?
Our Quality department is based on collaboration and partnership, with all of us working together to support and promote quality across the company.
What will You Do:
- The Regulatory Affairs Specialist will providing technical support to regulatory affairs management to ensure continuous compliance with domestic and international regulatory requirements. The RA Specialist will be responsible for supporting global product registrations, submissions, and licensing and USDA compliance.
Write, prepare, and manage regulatory submissions and filings required for U.S. FDA and other international authorities (i.e. 510(k), CE Marking, HC Medical Licensing).
Prepare documentation to support international registration dossiers and maintain product registration files and electronic databases.
Act as core member on project teams to provide regulatory guidance and strategic regulatory planning in support of new product development and existing product support.
Participate in inspections/audits by the notified body or other international regulatory agencies to include USDA by producing requested documents or answering any inquiries for information.
Assist in the development of regulatory best practices, processes and procedures.
BA or BS, preferably in a science discipline (i.e. Biology or Chemistry)
Minimum of 5 years experience in the medical device (IVD) regulatory affairs discipline: knowledge of domestic and international medical device/IVD regulation (i.e. Class I and II devices), practical experience in global registrations and filings (i.e. US, EU, Canada.)
Demonstrate strong attention to detail and solid interpersonal skills including the ability to work with teams and handle multiple ongoing projects.
Great verbal and written communication skills, working knowledge of MS Word, Excel, and other MS Suite applications.
Current knowledge of FDA 21 CFR Part 820, IVD Directive, and ISO standards.