Senior Regulatory Specialist - Device

Medasource; Philadelphia (Philadelphia County); Híbrido; USD 110.000 - 135.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory affairs

Clinical research

IDEs experience

FDA regulations

ICH/GCP knowledge

Communication skills

Project management

ACRP RAC certification

Descripción del empleo

Position: Senior Regulatory Specialist – Device

Location: Pennsylvania | Primarily Remote, onsite approximately 2 days/month

Contract Length: 6+ Months with potential to extend and/or convert to an FTE

Start Date: ASAP

Position Overview:

Our client is seeking a Senior Regulatory Specialist to support early-stage clinical research with a focus on investigational medical devices and neurology. This individual will play a key role in managing regulatory activities throughout the clinical research lifecycle, including FDA submissions, IDE activities, study documentation, and ongoing regulatory compliance.

The ideal candidate will have hands-on experience with Investigational Device Exemptions (IDEs), FDA regulatory submissions, and clinical research and be comfortable independently managing regulatory projects and providing guidance to investigators and study teams.

Key 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

Qualifications:

• 5–7 years of relevant regulatory affairs and/or clinical research experience
• Hands-on experience working with IDEs and investigational medical device studies
• Strong knowledge of FDA regulations and ICH/GCP requirements
• Experience preparing and managing FDA regulatory submissions
• Neurology or neuroscience experience strongly preferred
• Clinical trial experience preferred
• Experience with FDA electronic submission pathways and formats is preferred
• Strong written and verbal communication skills
• Ability to independently manage multiple projects and competing priorities
• Strong attention to detail, organization, critical thinking, and problem-solving skills
• ACRP and/or RAC certification preferred

This position is primarily remote with an expectation to be onsite approximately 2 days per month in Pennsylvania. Additional onsite time may be required during the first few weeks for onboarding and training.