Senior Clinical Safety Specialist

HISTOSONICS INC

16h • Remote

About The Position

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.

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.
• 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.

Nice To Haves

• Demonstrated experience in both pre-market and post-market safety activities, strongly preferred.

Responsibilities

• 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.

Benefits

• We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level