The Regulatory Affairs Manager will ensure that product, process, and procedures are sufficiently controlled to assure the quality of products and compliance in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVD 98/79/EC/ IVDR 2017/746, ISO 14971, Canadian Medical Device Regulation.
- Ensure compliance of all processes and procedures to applicable standards.
- Communicate with regulatory agencies, notified bodies, and competent authorities.
- Prepare and maintain product registrations that include substantial changes and new product submissions
- Renewals of Technical Files and communication with corresponding Agents (EU AR, China, and US FDA 510(k) Premarket Notifications)
- Prefer B.S. or B.A. in Microbiology, Biology, or Chemistry
- Five (5) years’ experience in Quality Assurance/Quality Control/Regulatory Affairs in a medical device discipline
- 2+ years of supervisory experience
- Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745,
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.