Regulatory Affairs Manager II Post Market

Regulatory Affairs Manager II Post Market focuses on develop a team of post-market regulatory professionals (set goals, conduct routine performance reviews, create development plans).

What the role involves

• Develop a team of post-market regulatory professionals (set goals, conduct routine performance reviews, create development plans).
• Leading team in assessing and documenting regulatory impact of design, labeling, and manufacturing changes to on-market devices.

Skills and requirements

• Requires a Bachelor degree, preferably in regulatory or science related areas.
• Minimum of 5 years of management experience in the medical device or IVD industry.
• Experience in managing a post-market program preferred.
• Knowledge of FDA 21 CFR , , , Health Canada Medical Device Regulation, European IVD Directive 98/79/EC and European IVD Regulation (EU) /, MDSAP Companion Document and ISO , prefer.

Additional role context

• Lead team in the timely completion of PMS Plans/Reports per IVDR and worldwide regulatory requirements.
• Lead team compliance with FDA adverse event reporting (e.g., 21 CFR Part – Medical Device Reporting) and other world vigilance reporting requirements.
• Review and approve labeling, advertising, and promotional materials for compliance.