Business Analysis, Business Practices, Channel Strategies, Claims Management, Communication Skills, Continuous Improvement, Cross-Functional, Documentation, Employee Retention, External Audit, FDA (Food and Drug Administration), FDA Requirements, Healthcare, ISO (International Organization for Standardization), Internal Audit, Interpret Regulations, Leadership, Maintain Compliance, Management Strategy, Manufacturing, Marketing, Medical Equipment, Mentoring, Physical Demands, Process Improvement, Product Development, Product Lifecycle, Product Lifecycle Management, Quality Assurance, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Regulatory Submissions, Research & Development (R&D), Research Laboratory, Risk, Risk Analysis, Risk Management, Safety Standards, Scalable System Development, Strategic Planning, Surveillance, Team Lead/Manager
Head of Regulatory Affairs
Company Overview
Founded in 1947, Pulpdent Corporation is an industry-leading dental research and manufacturing company. Pulpdent's corporate headquarters, research laboratory, and manufacturing facilities are located in Watertown, Massachusetts, in the Boston metro area. Its products are distributed globally. Pulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The enduring hallmarks of the Pulpdent brand are imagination, dedication, and empowerment, with each of these inspiring the daily work of Pulpdent's 100-plus employees. To learn more about Pulpdent, including its breakthrough advances in bioactive dental materials and commitment to ethical business practices, visit pulpdent.com.
Job Summary
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.
Essential Functions & Responsibilities:
Regulatory Strategy & Leadership
- 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.
U.S. & Global Regulatory Oversight
- 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.
Product Development & Lifecycle Management
- 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.
Quality System Collaboration
- 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.
Culture, Values & Cross-Functional Partnership
- 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.
Education & Experience
Required
- 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.
Preferred
- 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.
Work Environment & Physical Demands
- On-site role in Watertown, MA .
- Ability to complete regular walkthroughs of Pulpdent facilities, including production and R&D
Other duties as assigned
Other duties, responsibilities and activities may change or be assigned at any time with or without notice
PULPDENT is an equal opportunity employer. We employ a diverse workforce and encourage people of all backgrounds to apply for employment.