Clinical Compliance Manager

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:

Clinical Compliance Manager(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
As a Clinical Compliance Manager 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:

• Providing leadership and oversight for the team responsible for authoring and maintaining clinical evaluation documentation, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and associated processes.
• Allocating resources and monitoring timelines to ensure deliverables meet regulatory and business needs, and managing this process across the entire Dental Solutions product portfolio.
• Authoring and coordinating clinical evaluations for new products and legacy devices.
• Collaborating with cross-functional teams to generate a clinical evaluation that collects, analyses and assesses the clinical data pertaining to a medical device to verify the safety and performance in compliance with applicable regulations.
• Owning and continuously improving the clinical evaluation process, including developing SOPs, templates, and best practices for clinical evaluation documentation.
• Acting as the primary point of contact for audits and regulatory inspections related to clinical evaluation.

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 institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND seven (7) years of experience in the medical device industry
• Strong knowledge of EU MDR, MEDDEV 2.7/1 and clinical evaluations, including 5 years of experience medical writing according to EU MDR or comparable experience.
• 2+ years of experience managing teams and complex documentation processes.

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

• Dental experience in a private, public, government or military environment.
• Ability to work effectively in cross-functional and cross-cultural teams.
• Strong understanding of global regulatory requirements for medical devices.
• Excellent organizational, leadership, and communication skills.
• Proven strength in clinical and medical writing.
• Ability to manage multiple complex projects simultaneously.
• Strategic thinking, critical thinking, reasoning, and interpretive skills
• Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.
• Ability to leverage AI technologies to strategically optimize team workflows, drive automation of key processes, and elevate operational efficiency across the team.

Work location: Remote – United States

Travel: May include up to 10% domestic

Relocation Assistance: Not 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 $160,284 - $195,903, 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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