Job Description:
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 Youll Make in this Role
In this Senior Regulatory Affairs position, you will have the opportunity to act as the lead for regulatory affairs on cross functional teams and have ownership of product line submissions and registrations across the globe, for the dental solutions business. The role will have a significant impact for Tier 1 country registrations in high volume markets (US, Canada, EU, etc.). The position will work with the international regulatory affairs group to ensure products are registered globally based on the business strategy. In addition, you will have the opportunity to support labeling and registration changes to due the company spin-off.
As a Senior Regulatory Affairs Specialist (m/f/x)*, 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:
Conducting global regulatory change assessments and coordinating associated activities for assigned products.
Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills.
Providing regulatory review of technical reports and documents.
Providing contributions for development and implementation of regulatory processes.
Documenting and managing metrics.
Leading regulatory filings as needed for continuity projects (directly for EU/USA, and supporting ROW).
Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight.
Communicating results of technical tasks to teams supported, respective business group(s) and/or country/region served via reports, standards and/or presentations.
Leading the implementation of key corporate initiatives and appropriate tools.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Bachelors Degree or higher from an accredited university in a scientific discipline such as Biology, Chemistry, Biomedical Engineering or Physics.
7-10 years in regulatory affairs in the medical device industry
Direct experience authoring submissions/technical documentation for US, Canada, EU and supporting EMEA, APAC and LATAM regions
Direct experience authoring regulatory strategies and regulatory change assessments
Direct experience revising, reviewing and approving labeling (including marketing claims) that meet global regulatory requirements
Must have experience and expertise in design control verification and validation activities, as well as expertise in clinical requirements for medical devices; in particular, experience with assisting teams with documenting and performing