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Medical Writer - Clinical Compliance

Medical Writer - Clinical Compliance

SolventumSt Paul, MN, United States
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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 :

Medical Writer Clinical Compliance

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 Youll Make in this Role

As a Medical Writer Clinical Compliance , 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 :

Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs / CERs) to support new product introductions and existing products.

Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements.

Supporting internal and external audits as a subject matter expert in clinical evaluations.

Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices.

Contributing to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager / supervisor.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) one of the following education and experience combinations :

Bachelors degree or higher from an accredited institution AND three (3) years of experience in the medical device industry

OR

High School Diploma / GED from an accredited institution AND seven (7) years of experience in the medical device industry

AND

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

Three (3) years of experience in medical writing, preferably aligned to EU MDR clinical evaluation requirements

Knowledge of relevant regulatory guidelines, including EU MDR, FDA, NMPA, and associated clinical evaluation processes

Strong scientific writing and communication skills, with the ability to interpret and present clinical data

Proficiency in Microsoft Office tools (Word, Excel, Outlook, PowerPoint)

Demonstrated experience working on cross-functional teams in a global or regulatory environment

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

Strategic and critical thinking, with the ability to solve problems and adapt to shifting priorities

Familiarity with SSCP authoring and Class III / implantable medical device regulations in the EU

Excellent attention to detail, time management, and organizational skills

Work location : Remote

Travel : No travel required

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 $106,331 - $129,960, 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 candidates 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.

Solventum Global Terms of Use and Privacy Statement

Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.

Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the

terms.

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Medical Writer • St Paul, MN, United States

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