Regulatory Affairs Coordinator (Finance)

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:

Regulatory Affairs Coordinator

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

As a Regulatory Affairs Coordinator, 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 the Medical Surgical (MedSurg) Regulatory Operations team.
• Maintaining the FDA Establishment Registrations and Listings for medical devices, drug products, and cosmetics.
• Collaborate with Regulatory Affairs Associates and Specialists to review device, drug, and cosmetic listings, to either create/edit/deactivate. Ensure accurate and timely creation, update, and deactivation of device and drug listings in alignment with FDA requirements.
• Maintain the Certificate to Foreign Government (CFG) product lists.
• 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).
• Process certificates for authentication (e.g. notary, apostille, legalization)
• Monitor shared email inboxes for FDA and/or external customer requests, inquires.
• Assist with internal and external audits and inspections by regulatory authorities as needed.
• Support any other duties within the role or task assigned from time to time.

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 from an accredited university AND a minimum of one year of experience in Regulatory Affairs in a private, public, government or military environment

OR

• High School diploma AND five years of experience in Regulatory Affairs in a private, public, government or military environment

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

• Knowledge of ISO 13485, MDSAP, EU MDR, and other global regulatory frameworks.
• Strong organizational skills and attention to detail
• Excellent written and verbal communication skills
• Experience in medical device or pharmaceutical industry
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.

Work location:

• Remote.

Travel: May include up to 10% domestic/international

Relocation Assistance: NA

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.

Diversity & Inclusion

(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

Applicable to US Applicants Only:The expected compensation range for this position is $72,681 - $88,832, 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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