Clinical Affairs Specialist

Job Overview

Provides clinical expertise and cross-functional support for Clinical Affairs and education initiatives within Surgical Workflows. Collaborates with Product Management, Regulatory, Quality, Marketing, and R&D teams to support the development, evaluation, education, and commercialization of new and existing products. Serves as a subject matter expert in sterile processing and perioperative workflows by translating clinical practices and customer needs into educational resources, product insights, and workflow recommendations throughout the product development lifecycle.

Job Responsibilities and Essential Duties:

• Collaborate with Product Management, Quality, Regulatory, and R&D teams throughout the product lifecycle.
• Assist in development and review of clinical and technical product documentation.
• Provide logistical support to Clinical Affairs and Commercial Education activities, including planning, scheduling, tracking, and reporting.
• EDU Inbox Management – Actively monitors and responds to the EDU email inbox, addressing inquiries from sales reps, educators, and internal team members, or routing as appropriate.
• Healthmark Academy Administration – Manages the Healthmark Academy inbox, QR code generation, correspondence, flyer development, and reporting. Structural development and maintenance of educational programs.
• Speaking & Focused Assessment Coordination – Oversees speaking requests and focused assessment requests, including scheduling and customer/sales correspondence, through Monday.com. Manages and submits all CE programs for approval to the appropriate certification bodies and tracks them within Monday.com.
• Content Compliance & Audit Oversight – Audits Monday.com entries to ensure educators are uploading presentations, assessment reports, articles, and related materials for completeness and compliance.
• KPI Management – Enters and maintains departmental KPIs in 90.io for the full Clinical Affairs team and clinical leadership.
• Work closely with the Clinical Affairs leaders and the Marketing team to support educational and technical content needs for new and existing products, including educational documents, PowerPoint presentations, videos, and product research materials.
• Provide education in the form of video or live presentation/demonstration as needed.
• Summarize and translate technical and clinical information into content appropriate for non-technical audiences.
• Maintain records and files of work, revisions, approvals, and program documentation.
• Prepare training materials, supporting documents, and resources to communicate complex and technical information more easily.
• Work across teams to identify, collect, and organize new educational content for internal and external use.
• Produce high-quality documentation and educational support materials that meet applicable standards and are appropriate for their intended audience.
• Any other duties as assigned.

Required Knowledge, Skills and Abilities:

• Associate’s or Bachelor’s Degree in a related field (nursing, surgical technology, education, etc.) is preferred but not required.
• Experience as SPD Educator preferred.
• Additional sterile processing related certifications preferred (CHL, CIS, CER, etc.).
• Strong understanding of sterile processing workflows, infection prevention principles, and perioperative practices.
• Ability to support product lifecycle and commercialization activities.
• Exceptional attention to detail.
• Excellent communication and presentation skills (written and verbal).
• Proficient user of Microsoft Office Suite, Adobe Acrobat, Monday.com, LMS platforms, and related administrative systems.
• Local to Healthmark office in Fraser, Michigan. Would work in the office at least three days a week.

Minimum Requirements: 

• Five years of experience is required (i.e., within a Sterile Processing/Operating Room).
• Certification as a sterile processing technician (HSPA or CBSPD).

Quality Requirements:  

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

• Sit for long periods of time.
• Communicate with staff and customers.
• Stand for long periods of time.
• Take notes.
• Travel as needed.
• Lift up to 25 lbs.
• Solve problems.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.