Head of Regulatory Affairs

Pulpdent-Corporation

Watertown (MA)

On-site

USD 180,000 - 230,000

Full time

4 days ago

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Job summary

Pulpdent Corporation in Watertown, MA, seeks a Head of Regulatory Affairs to guide global regulatory strategy across R&D, manufacturing, and marketing. Lead a high-performing team, manage FDA submissions, and ensure compliance with EU MDR and ISO 13485.

This on-site role partners with R&D, quality, and operations to enable safe, compliant products worldwide. The ideal candidate has 10+ years in medical devices regulatory affairs, a strong leadership track record, and deep knowledge of

Qualifications

Bachelor's degree in a scientific, engineering, or healthcare-related field; advanced degree preferred.
10+ years of progressive regulatory affairs experience in medical devices; dental materials preferred.
Demonstrated leadership for regulatory teams and cross-functional initiatives.
Deep knowledge of FDA medical device regulations and international frameworks; EU MDR preferred.

Responsibilities

Define, lead, and optimize global regulatory strategies aligned with business goals.
Oversee regulatory submissions and registrations with FDA and international bodies.
Guide product development with regulatory input across lifecycle stages.
Collaborate with QA and production to ensure regulatory and QMS alignment.
Cultivate a culture of compliance and effective stakeholder communication.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

FDA regulations

Education

Bachelor's degree in science/engineering/healthcare

Advanced degree preferred

Tools

eQMS

ISO 13485 knowledge

Job description

Company Overview

Founded in 1947, Pulpdent Corporation is an industry-leading dental research and development (R&D) 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