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Solventum · 3 weeks ago

Clinical Compliance Manager

United States

Full-time

Remote

Senior Level

$160K/yr - $196K/yr

7+ years exp

Solventum is a new healthcare company focused on improving lives through innovative solutions. The Clinical Compliance Manager will lead a team in authoring and maintaining clinical evaluation documentation, ensuring compliance with regulations, and improving clinical evaluation processes.

Responsibilities

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

Qualification

Clinical Evaluation PlansClinical Evaluation ReportsEU MDR knowledgeMedical writingRegulatory requirementsMicrosoft Office proficiencyTeam managementAnalytical skillsLeadership skillsCommunication skillsOrganizational skillsStrategic thinkingCritical thinking

Required

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

Preferred

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