Senior Regulatory Affairs Specialist (Remote: United States)

SOLVENTUM

6d • $124,000 - $170,500 • Remote

About The Position

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. In this Senior Regulatory Affairs Specialist position, you will have the opportunity to act as the lead Regulatory Affairs associate on an enterprise-wide strategic initiative to optimize the business’s supply chain. The role will have a significant impact on the global strategy to make Solventum a stand-alone world class healthcare company. As a Senior 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 in a science or engineering discipline (completed and verified prior to start) AND five (5) years of experience in regulatory affairs in the medical device industry in a private, public, government or military environment OR High School Diploma/GED AND nine (9) years of experience in regulatory affairs in the medical device industry in a private, public, government or military environment
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
• Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
• Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Nice To Haves

• Experience working on combination medical devices with an antimicrobial
• Direct experience authoring regulatory submissions/technical documentation
• Direct experience authoring regulatory strategies and regulatory change assessments
• Experience working and providing regulatory support for new product development teams
• Experience developing regulatory strategies and project management.
• Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software

Responsibilities

• Supporting global regulatory strategies for changes related to on an enterprise-wide strategic initiative to optimize the business’s supply chain and ensuring these strategies are integrated with the overall RA plans.
• 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
• Demonstrating 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 (directly for EU/USA, Canada 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, 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.

Benefits

• Solventum offers many programs to help you live your best life – both physically and financially.
• To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
• Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

What This Job Offers

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