What are the responsibilities and job description for the Post Market Clinical Specialist position at Exactech?
Department: Quality
Location: Gainesville, FL
The Post-Market Clinical Specialist plays a critical role in ensuring the ongoing safety and performance of medical devices after they enter the market. This position involves clinical evaluation concerning complaint and adverse events and involves collaboration with cross-functional teams to maintain regulatory compliance and improve patient outcomes.
Key Responsibilities
- Supports the implementation and continuous improvement of complaint and adverse event coding terms and structure.
- Conducts clinical assessments of adverse events and complaints related to marketed medical devices.
- Supports adverse event/complaint investigations and regulatory reporting.
- Creates and supports the implementation of post market clinical white papers.
- Reviews and analyzes data related to complaints, adverse events, and customer feedback to identify potential issues or trends.
- Supports Risk Management processes and Health Hazard Evaluations (HHE).
- Owns and supports CAPA actions.
- Participates in preparation, analysis, and writing of ad-hoc and aggregate regulatory responses and reports.
- Supports audits and audit requests for complaints; may act as subject matter expert during audits.
- Assists and supports other employees, teams, and sales personnel as necessary.
- Practices Exactech’s Values & Mission.
- Knows and applies Exactech’s Quality System and any appropriate FDA and World-wide standards.
Education:
- Registered Nurse (RN) with active U.S. license.
- Bachelor’s degree in Nursing or related field (BSN preferred).
- Minimum 3 years of medical device experience, either in a clinical setting or within the medical device industry. Experience with joint arthroplasty is preferred.
- Familiarity with US FDA regulations, including 21 CFR 820, 21 CFR 803, and 21 CFR 806. Direct experience is preferred.
- Familiarity with vigilance requirements of the EU Medical Device Regulation (MDR) No. 2017/745 for medical devices to include notification and evaluation of serious incidents.
- Familiarity with ISO 13485 and ISO 14971.
- Strong understanding of physiological, anatomical, biomechanical, pathological, and neuropsychological principles and mechanisms of human movement.
- Strong analytical and problem-solving skills with the ability to identify and solve complex problems related to medical device safety and performance.
- Detail-oriented with a commitment to maintaining high-quality standards.
- Excellent verbal and written communication skills.
- Detail-oriented with strong organizational skills.
- Creative problem-solving and critical thinking skills.
- Ability to collaborate effectively as a team member across various functions and subject areas in a challenging and changing environment.
- Strong technical writing skills.
- Working knowledge of MS Office database platforms, spreadsheets, and data analytics/graphical presentation programs.