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Regulatory Affairs Specialist
| Company | H.B. Fuller |
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| Location | Granite Falls, NC, USA |
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| Salary | $26 – $26 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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Requirements
- 3 years related experience with HS Diploma (preferably in a cGMP environment); 2 years related experience with associate’s degree; or a Bachelor degree with no experience.
- Fluent in English
- Demonstrates proficiency in the following competencies: Innovation, Accountability, Performance Excellence, Change and Risk Taking, Customer Focus, Teamwork.
Responsibilities
- Acts as a resource to operations teams and problem-solving groups and aids in resolution of problems.
- Assists Operations and Quality Operations in implementing corrective action for process deviations, assisting with CAPA initiatives.
- Acts as a resource for our internal and external customers in quality questions.
- Provide timely feedback to customers with complaints.
- Document and submit Medical Device Reports as necessary, and as needed, work with international distributors for Medical Device Reports.
- Supports audits from a complaint and CAPA perspective.
- Assures that operators are following written instructions and methods and procedures via real-time record review.
- Assist with trainings, Management Review, and other administrative tasks as needed.
Preferred Qualifications
- Quality experience in a Quality Assurance arena highly preferred.
- Direct experience of working with ISO 13485, FDA 21CFR Part 820 and FDA 21 CFR Part 11 preferred.
- Experience with eQMS systems preferred.
- Prior medical device, ISO 13485, MDSAP, EU MDR or single use experience preferred.
