Quality Specialist - Regulatory Affairs
Overview:
Join an industry leading biotech organization leading development of In vitro Diagnostic Medical Devices.
This expert role within the Quality Assurance team involves supporting regulatory activities for In vitro Diagnostic Medical Devices. You will be reporting to and collaborating with the QA Manager. Responsibilities include researching and communicating regulatory requirements, assisting with submissions, and creating documentation. Key areas are device labeling and safety. The role also involves liaising with regulatory bodies, providing technical support for validations, and managing process improvements. In new product development, the position defines regulatory requirements and supports onboarding and labeling processes.
Key Responsibilities:
- Assist with regulatory submissions and compliance research.
- Ensure safety program compliance in product regions.
- Maintain IVDR approvals, Post Market Surveillance and regulatory reporting.
- Ensure QMS compliance with ISO 13485, ISO 9001, and other standards.
Additional Responsibilities:
- Support validation activities and risk management.
- Draft QMS documents.
- Assist with audits and supplier evaluations.
- Support training, nonconformance investigations, and CAPA.
- Manage labeling process/change controls.
- Collaborate with departments on quality, regulatory, and safety functions.
- Support product development processes.
Requirements:
- Associates degree in science or related field, or equivalent experience.
- 2+ years in Quality Assurance, Regulatory Affairs, or related field.
Preferred Qualifications:
- Experience with IVD/IVDR, MDD/MDR, or FDA regulations.
- Regulatory compliance/submissions experience.
- Quality Engineering/process improvement experience.
- Knowledge of ISO 9001, ISO 13485, 21 CFR 820, or equivalent.
Ready to make a difference? Join and be part of a team that's transforming the future of healthcare.
