Medical Writer - Clinical Compliance at Solventum | Torre

Medical Writer - Clinical Compliance

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Full-time

Legal agreement: Employment

Compensation
USD124k - 170k/year
location_on
Remote (for United States residents)
Shared by
Julien PETIT
about 2 months ago

Responsibilities


The Impact You’ll Make in this RoleAuthoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit.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 ExpertiseTo set you up for success ventum 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 five (5) years of experience in the medical device industryAND following are also required:Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably aligned to EU MDR requirementsAdditional qualifications that could help you succeed even further in this role include:Strong scientific writing and communication skills, with the ability to interpret and present clinical dataDental experience in a private, public, government or military environmentDemonstrated experience working on cross-functional teams in a global or regulatory environmentFamiliarity with SSCP authoring and Class III/implantable medical device regulations in the EUExcellent attention to detail, time management, and organizational skillsAbility to manage multiple complex projects simultaneously.Strategic thinking, critical thinking, reasoning, and interpretive skillsProficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.Experience utilizing AI technologies to optimize workflows, automate tasks, and enhance operational efficiency.Travel: May include up to 10% domesticRelocation Assistance: Not authorizedMust be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-beingSolventum 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 $124,000 - $170,500, 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. s 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-RewardsResponsibilities 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.