Principal Regulatory Affairs Specialist (Remote - United States)
$142,800–$196,350 year
RemoteUnited States
Job Summary
Lead cross-functional teams on product-line regulatory submissions and registrations for the Dental Solutions business across global markets. Drive regulatory strategy and execution for Tier 1 markets including the United States, Canada, and the European Union while partnering with international teams to ensure global product alignment. Conduct global regulatory change assessments and coordinate activities for assigned drug and medical device products. Lead or support regulatory filings for continuity and lifecycle projects directly for the US and EU markets. Provide regulatory review and input on technical documentation, including support for labeling and registration updates related to the company spin-off. Develop and improve regulatory processes, manage relevant metrics, and support risk management, vigilance reporting, and quality initiatives. Communicate regulatory outcomes and technical information to cross-functional teams, business partners, and regional stakeholders through reports and presentations. Implement key corporate initiatives and emerging digital and AI-enabled solutions within the regulatory environment.
Required Qualifications
- Bachelor's Degree or higher (completed and verified prior to start)
- Seven (7) years in regulatory affairs experience in the drug and/or medical device industry
- Experience authoring regulatory submissions and technical documentation for drug and medical device products in the United States, Canada, and the European Union
- Experience supporting regulatory activities in EMEA, APAC, and LATAM
- Experience authoring regulatory strategies and regulatory change assessments
- Experience revising, reviewing, and approving product labeling, including marketing claims, to ensure compliance with global regulatory requirements
- Experience with NDA and OTC monograph drugs and medical devices
- Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status)
- Must not perform work in the unincorporated areas of Los Angeles County
Desired Qualifications
- Bachelor's Degree or higher (completed and verified prior to start) in Biology, Chemistry, Biomedical Engineering
- Experience with dental products
- Experience supporting design control verification and validation activities, including clinical requirements for medical devices, such as documenting and performing to applicable requirements and supporting the writing, review, and approval of protocols and reports
- Experience supporting or contributing to clinical strategy activities for medical device products
- Experience working with formulated products
- Experience working with fluoride‐containing drug and medical device products
- Experience working with borderline products, such as drugs, cosmetics, and/or natural health products
- Experience applying regulatory knowledge through cross‐functional project management, including stakeholder engagement, international submission support, and resolving regulatory issues across medical device product teams
- Experience applying regulatory principles and professional practices to address complex regulatory issues, including development of clear regulatory documentation and written communications
- Experience applying structured process‐improvement approaches within regulatory or quality‐related workflows, including participation in training or professional development activities
- Experience working across multiple product portfolios, technologies, or business areas, including use of regulatory information resources, systems, and data sources to build regulatory understanding and support decision‐making
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