Clinical Compliance Manager
Solventum
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $160,284 - $195,903 per year
Job Level
SeniorLead
About the role
- 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.
Requirements
- Bachelor’s degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.)
- 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
- 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.
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical evaluation documentationClinical Evaluation Plans (CEPs)Clinical Evaluation Reports (CERs)medical writingEU MDRMEDDEV 2.7/1clinical evaluationsSOPsanalytical skillsproject management
Soft skills
leadershiporganizational skillscommunication skillsstrategic thinkingcritical thinkingreasoninginterpretive skillscollaborationcross-functional teamworkcross-cultural teamwork