Head of Regulatory Affairs

Pulpdent Corporation•Watertown, MA

2d•Onsite

About The Position

The Head of Regulatory Affairs will lead and evolve Pulpdent’s global regulatory strategy across the full product lifecycle—from R&D and commercialization to quality assurance and post-market surveillance. This role is responsible for ensuring compliance with domestic and international regulatory requirements while serving as a strategic partner to other business leaders, including those in R&D, manufacturing, and marketing. As a key member of the leadership team, the Head of Regulatory Affairs will build scalable systems, mentor regulatory talent, and help guide the company’s growth into new geographic markets and product categories while maintaining Pulpdent’s high standards of safety, quality, and compliance.

Requirements

Bachelor’s degree in a scientific-, engineering-, or healthcare-related field; advanced degree preferred.
10+ years of progressive regulatory affairs experience in medical devices; exposure to dental or related materials preferred.
Demonstrated leadership experience managing regulatory teams and cross-functional initiatives.
Deep knowledge of FDA medical device regulations and international frameworks; EU MDR strongly preferred.
Proven experience leading successful regulatory submissions and agency interactions.

Nice To Haves

Experience in a manufacturing environment, ideally with in-house production.
Familiarity with chemical-based or materials-driven medical devices.
RAC certification or equivalent professional credentials.

Responsibilities

Define, develop, and lead strategies to maximize global regulatory success in pursuit of Pulpdent business objectives.
Serve as the primary authority to executive leadership on regulatory risk, opportunity, and readiness.
Provide leadership and development for a high-performing regulatory affairs team.
Promote high standards of collaboration between the regulatory team and other departments.
Oversee regulatory submissions (510(k)s, technical files) and registrations (FDA Class I & II, devices), 510(k)s, technical files, and international registrations (EU MDR, UKCA, etc.).
Act as primary point of contact with regulatory agencies and notified bodies.
Monitor and interpret evolving regulatory requirements and proactively assess business risks and opportunities.
Partner closely with R&D and product to anticipate regulatory requirements early and often in product development process.
Provide regulatory guidance on product changes, labeling requirements, claims, and risk management strategies.
Ensure compliant post-market activities, including vigilance reporting complaints, and field actions.
Drive continuous improvement of regulatory processes and documentation systems.
Master an understanding of Pulpdent’s eQMS; guide an implementation strategy to optimize efficiency and accurate maintenance.
Collaborate with production to ensure alignment between regulatory expectations and QMS (e.g., ISO 13485, FDA QSR).
Oversee internal and external audits, inspections, and remediation activities.
Champion a culture of compliance, transparency, and scientific integrity.
Balance regulatory rigor with practical, business-minded solutions in a consensus-driven, family-owned environment.
Communicate clearly and effectively with technical and non-technical stakeholders.