MB&A

Lead and execute global regulatory strategies and filings for Class II-III medical devices, biologics, and combination products. Perform hands-on quality engineering activities, including QMS support, CAPA, and managing relationships with the FDA and Notified Bodies.

Lead strategic quality initiatives and project leadership for med-tech and life sciences clients. Execute quality engineering activities across the product lifecycle, including eQMS optimization and regulatory compliance management.

Provide senior-level project leadership for quality initiatives and personally execute quality engineering activities across the product lifecycle. Drive hands-on implementation of electronic Quality Management Systems and support manufacturing transfers and regulatory inspections.

The Principal Regulatory Consultant will lead and execute global regulatory strategies for medical devices and biologics, preparing and submitting various regulatory filings. They will also drive compliance activities and serve as a liaison with regulatory bodies.