Senior Staff Clinical Evaluation Specialist

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Spearhead the creation and implementation of clinical evidence strategies for new product innovation and lifecycle management initiatives.

• Oversee clinical evaluation projects, ensuring alignment between clinical evidence, regulatory strategy, product claims, and commercialization goals.

• Write and maintain clinical evaluations, post-market clinical follow-up reports, safety and performance summaries, regulatory submissions, annual reports, and other clinical documentation.

• Design and conduct systematic literature reviews, assess published evidence, and integrate clinical, preclinical, and post-market data.

• Evaluate medical-device benefit-risk profiles and formulate evidence-based recommendations in compliance with global regulatory standards.

• Collaborate with regulatory bodies and internal stakeholders to fulfill clinical evidence requirements and facilitate regulatory submissions.

• Create scientific communications, including manuscripts, conference abstracts, presentations, white papers, and customer-facing evidence materials.

• Provide mentorship to team members, guide cross-functional review processes, and enhance clinical evaluation methodologies, documentation practices, and team productivity.

• Work in partnership with Regulatory Affairs, Clinical Research, Marketing, Reimbursement & Market Access, Quality, and Product Development teams.

• Travel requirement: 10%

⛳️ Requirements

• A Master of Science degree in a health, clinical, biological science, biomedical, engineering, or a related scientific discipline.

• At least 6 years of experience in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, post-market surveillance, or related medical device roles.

• A minimum of 2 years of experience in authoring clinical evaluations for medical devices.

• Proficiency in conducting literature reviews, evidence synthesis, and scientific analysis utilizing clinical and technical data.

• Experience in supporting regulatory submissions and product lifecycle processes within a regulated healthcare sector.

• Fluency in English is required.

• Preferred: A Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related field.

• Preferred: Experience in navigating global medical device regulatory requirements, including clinical evaluation, post-market surveillance, and market access activities.

• Preferred: Background in developing scientific publications, conference presentations, and clinical evidence communication strategies.

• Preferred: Experience in managing complex cross-functional projects within the medical device sector.

• Candidates must reside in the Eastern or Central time zones.

🏝️ Benefits

• Flexibility for remote, hybrid, or onsite work arrangements.

• Remote position available within the United States for candidates located in Eastern or Central time zones.

• Commitment to equal opportunity employment.

• Pay transparency protections.

• 10% travel allowance/coverage.