Regulatory Affairs Specialist

SOLVENTUM

1d • Remote

About The Position

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 In this regulatory affairs position, you will have the opportunity to support regulatory affairs on cross functional teams and have ownership of processes in Regulatory Operations, for the dental solutions business. Regulatory Operations (RegOps) is the practical arm responsible for managing the processes involved in regulatory submissions and approvals, handling the logistics of document preparation, submission, and tracking, ensuring that regulatory submissions are accurate, complete, and submitted on time. The position oversees RIM systems, which centralize regulatory data and streamline processes and will work with the international regulatory affairs group to ensure products are registered globally following established processes. In addition, you will have the opportunity to support Regulatory Operations during the company spin-off. As a 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:

Requirements

• Bachelor’s Degree or higher from an accredited university
• 2+ years in regulatory affairs, with knowledge of ISO 13485, MDSAP, EU MDR, and other global regulatory frameworks.
• Experience authoring submissions/technical documentation for global regions
• Direct experience authoring regulatory strategies and regulatory change assessments.
• Direct experience using a Regulatory Management Software solution.
• Direct experience in major cross functional initiatives/projects.
• Proficient in Office Suite.
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

• Experience working in the dental device field or with dental products
• Experience working with formulated products
• Soft skills: Customer service approach to support internal and external customers
• Expert technical writing skills in the English language.

Responsibilities

• Supporting certificate requests for ongoing country registrations. This includes Certificates to Foreign Government (CFG), Certificates of Pharmaceutical Product (CPP), Certificates of Free Sale (CFS), Letters of Authorization (LoA), and Powers of Attorney (PoA).
• Contributing to the development, implementation, maintenance and optimization of regulatory processes.
• Documenting and managing metrics.
• Communicating results of technical tasks to teams supported respective business group(s) and/or country/region served via reports, standards and/or presentations.
• Supporting the implementation of key corporate initiatives and appropriate tools.
• 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.
• Monitoring shared email inboxes for FDA and/or external customer requests/inquires.
• The job also requires performing other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level