Senior Regulatory Affairs Specicalist

Job Description

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. 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:

Senior Regulatory Affairs Specialist (Solventum)

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 Senior Regulatory Affairs position, you will have the opportunity to act as the lead for Regulatory Affairs on cross functional teams in new product development and sustaining projects for the Dental Solutions Division. 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.

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:

Conducting change impact assessments and coordinating associated activities for assigned products.

Supporting new product development as required.

Reviewing claims and promotional items with minimal oversight.

Supporting Clinical Strategy Development.

Providing regulatory review of technical reports and documents.

Acting as an SME and providing Regulatory Support for Audits (internal and external).

Participating on technical committees developing industry standards, guidances and/or regulations.

Supporting major contributions for development and implementation of regulatory processes.

Documenting and managing metrics.

Leading all types of regulatory filings (directly for EU/USAC and supporting to ROW) for US Class I and II devices and drugs.

Supporting issues reviews/risk management/vigilance reporting activities with minimal oversight, if any.

Drafting NPI regulatory strategy with minimal oversight.

Developing familiarity with leading key negotiations and interactions with regulatory authorities.

Communicating results of technical tasks to teams supported, respective business group(s) and/or country/region served, and/or appropriate technical community via reports, standards and/or presentations.

Communicating to external third parties/customers as appropriate

Demonstrating awareness of confidential business information and the required obligations.

Conducting training of personnel and/or business teams.

Exercising professional judgment in evaluating results and defines future direction based on these results.

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:

Bachelor’s Degree or higher AND (5) years of experience in regulatory affairs

OR

High School Diploma/GED from AND (9) years of experience in regulatory affairs

AND

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

Direct experience authoring US, Canada and EU submissions/technical documentation

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

Experience developing regulatory strategies, label and claims review and project management

Regulatory acumen, cross functional project management, stakeholder management, EU MDR, international submission support, Medical Devices, Drugs and Personal Health products, proficient in Office Suite and Regulatory Management Software

Possesses thorough understanding of concepts and professional practices to solve complex and diverse regulatory problems

Applies methodology of process improvement when applicable

Maintains broad knowledge of assigned organization’s products, broad industry trends, and customer needs

Capable of developing understanding of technologies and/or products across multiple divisions

Possess knowledge of and regularly utilizes available information resources and systems

Collaborates with colleagues to innovate, influence, and/or negotiate when required

Possesses skills to begin mentoring others

Work location: Remote – United States

Travel: May include up to 10% domestic/international

Relocation Assistance: May be authorized

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 $137,439 – $167,981, 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.

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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