Director of Quality & Regulatory

Director of Quality & Regulatory at Barrington James Director of Quality & Regulatory at Barrington James in Winthrop, Massachusetts Posted in 5 days ago.

Type:

full-time

Job Description:

Director of Quality & Regulatory Medical Device Currently supporting a growing, founder-led medical device manufacturing organisation seeking a Senior Quality & Regulatory leader to join at a pivotal stage of expansion and operational transformation. The business operates across multiple US sites and supports the development and manufacture of high-quality Class II medical devices within a fast-paced contract manufacturing environment. With a strong pipeline of products and increasing customer demand, this is a key leadership hire responsible for strengthening quality systems, driving compliance excellence, and embedding structure across a scaling organisation. This individual will take ownership of the overall Quality and Regulatory function, leading both strategic and hands-on operational quality activities across multiple manufacturing sites. The role will play a critical part in QMS remediation and consolidation following a legacy dual-system environment and will act as the key point of leadership for FDA, customer, and notified body interactions.

Key Responsibilities:

Lead the overall Quality and Regulatory function across multiple US manufacturing sites Own and drive QMS remediation, consolidation, and continuous improvement activities Act as primary lead for FDA inspections, notified body audits, and customer audits Oversee quality systems across design, manufacturing, and post-market surveillance Provide leadership and oversight of design quality engineering and QC functions Manage and develop a team of quality professionals (approx. 5 direct and indirect reports) Partner closely with engineering and operations to ensure quality is embedded across all processes Act as the key quality authority, balancing compliance requirements with operational delivery Support regulatory activities including device registrations, UDI, and FDA submissions as required Drive a culture of accountability, continuous improvement, and operational excellence

Key Requirements:

Experience in medical device Quality and Regulatory leadership roles Strong background in Class II medical devices and

ISO 13485 / 21 CFR 820

environments Proven experience leading FDA inspections and external audits Demonstrated experience in QMS implementation, remediation, or consolidation Background in contract manufacturing or multi-site manufacturing environments strongly preferred Experience managing cross-functional teams within QA/QC and design quality environments Strong leadership capability with proven ability to develop and mentor teams Ability to influence and collaborate effectively with engineering and operations functions Strong communication skills with the ability to operate in a fast-paced, hands-on environment Comfortable working in a founder-led, growing organisation with evolving structure Ability to operate onsite across multiple manufacturing locations as required Apply today to learn more or reach out directly to rbanton@barringtonjames.com