Senior Regulatory Specialist – Medical Devices (Remote, IDEs)

Medasource; Philadelphia (Philadelphia County); Hybrid; USD 110,000 - 135,000; Full time

Job summary

Medasource is seeking a Senior Regulatory Specialist to oversee regulatory activities for investigational medical devices and neurology programs. The role includes managing FDA submissions, IDE activities, and study documentation throughout the clinical lifecycle.

You will lead regulatory assessments, facilitate communications with FDA and other agencies, maintain TMFs, and support study initiation, ongoing oversight, and closeout across Phase I–IV trials, primarily remote with occasional onsite

Qualifications

• 5–7 years of regulatory affairs and/or clinical research experience.
• Hands-on IDEs and investigational device studies experience.
• Strong knowledge of FDA regulations and ICH/GCP.
• Experience preparing FDA regulatory submissions.
• Neurology or neuroscience experience strongly preferred.
• Clinical trial experience preferred.
• Experience with FDA electronic submission pathways and formats is preferred.
• ACRP and/or RAC certification preferred.

Responsibilities

• Prepare and manage FDA regulatory submissions, including IDE applications, Q-Submissions, amendments, annual reports, adverse event reports, and other required submissions.
• Support regulatory activities for Phase I–IV clinical research and investigational medical device studies.
• Author, review, and conduct regulatory assessments of study documents, including protocols, informed consent forms, investigator brochures, briefing books, and sponsor reports.
• Facilitate regulatory communications with the FDA and other applicable regulatory agencies.
• Maintain regulatory documentation and Trial Master Files (TMFs) and ensure assigned studies remain audit and inspection ready.
• Support study initiation, ongoing oversight, protocol compliance, and study closeout activities.
• Review safety information and assess potential regulatory impacts to ongoing studies.
• Provide regulatory and compliance guidance to investigators, research teams, and other stakeholders.
• Support the development of SOPs, work instructions, templates, and other regulatory tools.
• Assist with training and mentoring team members on regulatory processes and requirements.
• Coordinate with vendors and study teams to resolve regulatory and data-related questions.

Skills

Regulatory affairs

Clinical research

IDEs experience

FDA regulations

ICH/GCP knowledge

Communication skills

Project management

ACRP RAC certification

Job description

Medasource is seeking a Senior Regulatory Specialist to oversee regulatory activities for investigational medical devices and neurology programs. The role includes managing FDA submissions, IDE activities, and study documentation throughout the clinical lifecycle.

You will lead regulatory assessments, facilitate communications with FDA and other agencies, maintain TMFs, and support study initiation, ongoing oversight, and closeout across Phase I–IV trials, primarily remote with occasional onsite