Regulatory Affairs Manager to Associate Director
Principal Regulatory Affairs Specialist
Remote (U.S.) | $142.8K - $196.4K Base Salary
An industry-leading healthcare and medical technology organization is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategy and submissions for a portfolio of dental drug and medical device products. This individual will serve as the Regulatory Affairs lead on cross-functional teams, driving registration, compliance, and lifecycle management activities across major global markets, including the United States, Canada, and European Union.
This position will play a critical role in developing regulatory strategies, authoring submissions, conducting regulatory change assessments, supporting product registrations worldwide, and ensuring ongoing compliance throughout the product lifecycle. The role also involves collaborating with Quality, R&D, Clinical, Marketing, and international regulatory teams to support product launches, labeling updates, risk management activities, and process improvement initiatives.
Key Qualifications
- Bachelor's degree and 7+ years of Regulatory Affairs experience within the medical device and/or pharmaceutical industry
- Strong experience with regulatory submissions and technical documentation for the U.S., Canada, and EU
- Expertise in regulatory strategy development, change assessments, and lifecycle management
- Experience reviewing product labeling, claims, and promotional materials for global compliance
- Working knowledge of NDA, OTC monograph drugs, and medical device regulatory requirements
- Ability to work effectively across cross-functional and international teams
Preferred Experience
- Dental products and technologies
- Design controls, verification & validation, and clinical support activities
- Fluoride-containing products, formulated products, and borderline products (drug/device/cosmetic combinations)
- Global regulatory submissions across EMEA, APAC, and LATAM markets
- Process improvement initiatives and regulatory project leadership
Additional Details
- Location: Remote within the United States
- Travel: Up to 10% domestic and international travel
- Compensation: $142.8K - $196.4K per year plus potential incentive compensation and comprehensive benefits package
This is an excellent opportunity for a senior Regulatory Affairs professional looking to take ownership of global regulatory strategy while supporting innovative medical device and pharmaceutical products in a highly visible leadership role.
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