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Senior Clinical Safety Specialist
Location
United States
Posted
111 days ago
Salary
0
No structured requirement data.
Job Description
Senior Clinical Safety Specialist
HISTOSONICS INC
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Clinical Safety Specialist is responsible for supporting the clinical safety strategy, oversight, and management of safety-related activities for the company's medical device portfolio. This role ensures compliance with global safety regulations and standards, provides scientific and clinical safety expertise throughout product development and post-market phases, and supports risk management activities in collaboration with cross-functional teams. - Serve as a clinical safety expert for assigned medical devices throughout the product lifecycle — from development through post-market surveillance. - Support in the development, implementation, and maintenance of clinical safety governance frameworks, policies, and procedures. - Support clinical safety review boards and safety data evaluations in collaboration with clinical, regulatory, and quality teams. - Oversee identification, evaluation, and communication of safety signals from clinical trials, post-market data, and literature. - Support preparation and review of clinical safety deliverables (e.g., safety narratives, adverse event summaries, safety sections of clinical study reports). - Partner with Regulatory and Quality Assurance to support device risk management files, benefit-risk assessments, and periodic safety updates. - Support vigilance reporting and field safety corrective actions (FSCAs) as needed. - Collaborate with other Clinical Affairs members, R&D, Quality, and Regulatory teams to ensure clinical safety considerations are integrated into product design and development. - Provide input to clinical study protocols, informed consent forms, and investigator training related to safety. - Participate in regulatory submissions (e.g., IDEs, PMAs, 510(k)s, MDRs, CE marking, etc.) ensuring safety content is complete and accurate. - Ensure all safety activities comply with applicable global regulations (e.g., FDA, ISO 14155, MDR, EU-MDR Article 2(58), MDCG2020-10/1, ISO 14971). - Monitor and interpret evolving safety regulations and standards to ensure proactive compliance. - Drive continuous improvement initiatives in safety systems, processes, and reporting. - Other duties as assigned. Qualifications - Bachelor’s degree in relevant area of study. - Minimum of 5 years experience in the medical device industry, including experience with clinical safety or risk management. - Experience with medical device safety reporting requirements (e.g., MDR, FDA, ISO 14155/14971) essential. - Demonstrated experience in both pre-market and post-market safety activities, strongly preferred. - Strong understanding of global safety regulations and quality management systems. - Excellent analytical and clinical judgment skills. - Ability to synthesize complex clinical data and communicate clearly to technical and non-technical audiences. - Strong project management skills. - Exceptional written and verbal communication abilities. Benefits - Comprehensive benefits package for full-time employees. - Health, dental, and vision insurance. - Life, short-term and long-term disability insurance. - 401(k). - Paid time off. - And more.
Job Requirements
- Bachelor’s degree in relevant area of study.
- Minimum of 5 years experience in the medical device industry, including experience with clinical safety or risk management.
- Experience with medical device safety reporting requirements (e.g., MDR, FDA, ISO 14155/14971) essential.
- Demonstrated experience in both pre-market and post-market safety activities, strongly preferred.
- Strong understanding of global safety regulations and quality management systems.
- Excellent analytical and clinical judgment skills.
- Ability to synthesize complex clinical data and communicate clearly to technical and non-technical audiences.
- Strong project management skills.
- Exceptional written and verbal communication abilities.
Benefits
- Comprehensive benefits package for full-time employees.
- Health, dental, and vision insurance.
- Life, short-term and long-term disability insurance.
- 401(k).
- Paid time off.
- And more.
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