Principal Regulatory Affairs Specialist
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our 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. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
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. Here, you will make an impact by:
- 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
Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
- Bachelor's Degree or higher (completed and verified prior to start) AND seven (7) years in regulatory affairs experience in the drug and/or medical device industry
In addition to the above requirements, the following are also required:
- Experience authoring regulatory submissions and technical documentation for drug and medical device products in the United States, Canada, and the European Union, with 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
Additional qualifications that could help you succeed even further in this role include:
- 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…
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