Regulatory Affairs Specialist

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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 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:

• 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.  Percentages of time spent on job duties are estimates and may vary.

A successful candidate for this role:

• Possesses thorough understanding of concepts and professional practices to solve complex and diverse regulatory problems.
• Has exceptional attention to detail, written and oral communication skills.
• Applies methodology of process improvement when applicable.
• Utilizes strong technical and non-technical communication skills of listening, reading, writing, and speaking and continuously improves these skills through regular participation in appropriate training activities.
• Maintains broad knowledge of assigned organization's products, broad industry trends, and customer needs. 
• Can develop understanding of technologies and/or products across multiple divisions.
• Possesses knowledge of and regularly utilizes available information resources and systems.
• Collaborates with colleagues to innovate, influence, and/or negotiate when required.

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 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

In addition to the above requirements, the following are also required:

• 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.

Additional qualifications that could help you succeed even further in this role include:

• 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.

Work location: Remote

Travel: May include up to 10% international

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being 

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. 

Applicable to US Applicants Only:The expected compensation range for this position is $85,200 - $117,150, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

   

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.

Solventum is an equal opportunity employer.  Solventum  will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

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.

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