Principal Regulatory Affairs Specialist (Remote - United States)

SOLVENTUM

3d•Remote

About The Position

Solventum is a new healthcare company with a long legacy of creating breakthrough solutions for customers' toughest challenges. We pioneer game-changing innovations at the intersection of health, material, and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. As a Principal Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. This role involves serving as the regulatory affairs lead on cross-functional teams, driving regulatory strategy and execution for key global markets, and ensuring products are registered globally in alignment with business strategy. You will also conduct global regulatory change assessments, lead or support regulatory filings for continuity and lifecycle projects, and provide regulatory review and input on technical documentation. Additionally, you will contribute to the development and improvement of regulatory processes, support risk management and vigilance reporting, and communicate regulatory outcomes to various stakeholders. The role also involves supporting key corporate initiatives and enabling tools, including the use of digital and AI-enabled solutions within the regulatory environment.

Requirements

Bachelor’s Degree or higher (completed and verified prior to start)
Ten (10) 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 dental products, including 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)

Nice To Haves

Bachelor’s Degree or higher (completed and verified prior to start) in Biology, Chemistry, Biomedical Engineering
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

Responsibilities

Serving as the regulatory affairs lead on cross‑functional teams, with ownership of product‑line regulatory submissions and registrations for the Dental Solutions business across global markets
Driving regulatory strategy and execution for Tier 1, high‑volume markets, including the United States, Canada, and the European Union, while partnering with international regulatory affairs teams to ensure products are registered globally in alignment with business strategy
Conducting global regulatory change assessments and coordinating associated activities for assigned drug and medical device products
Leading or supporting regulatory filings for continuity and lifecycle projects, directly for the United States and European Union and in partnership with global teams for rest‑of‑world markets
Providing regulatory review and input on technical documentation and reports, including support for labeling and registration updates related to the company spin‑off
Contributing to the development, implementation, and continuous improvement of regulatory processes, including documentation and management of relevant metrics
Supporting risk management, vigilance reporting, and other quality‑related initiatives with minimal oversight
Communicating regulatory outcomes and technical information to cross‑functional teams, business partners, and regional stakeholders through reports, standards, and presentations
Supporting the implementation of key corporate initiatives and enabling tools, including use of emerging digital and AI‑enabled solutions within the regulatory environment