Regulatory Affairs Specialist jobs in Binghamton, NY

Regulatory Affairs Specialist – Ithaca, NY

Onsite Position

Job Description

This position will support worldwide regulatory registrations for our current and future medical devices as well as support process compliance in conjunction with our engineering, regulatory and quality departments. All candidates should have experience in technical reading and writing, and a basic understanding of regulatory affairs and quality assurance.

Roles & Responsibilities

• Remain current on all applicable regulatory guidance’s that impact the company’s ability to legally market medical devices around the world and assist in updating relevant SOPs based on those changes.
• Remain current with all mandatory and recommended certifications, processes, and applicable standards as they relate to global regulatory compliance and assist in updating relevant SOPs based on those changes.
• Assist in the creation of regulatory documentation in conjunction with the Engineering team that can be used to support FDA, EU and other worldwide regulatory submissions.
• Support Transonic during audits with regulatory agencies or notified bodies.
• Support registration activities with our distribution channels through creation and provision of the applicable regulatory documents and filings.
• Maintain documentation and certifications for all country-based registrations.
• Create gap analyses and remediation plans for identified gaps when standards are updated and drive project teams to fulfill those remediation plans.
• Review Marketing Communications, Instructions for Use and other technical documentation to ensure they comply with regulatory claims standards.
• Perform training on regulatory procedures and updates on guidance’s to company personnel.
• Facilitate the Risk Management Process in compliance with applicable external standards and corporate policies.
• Work with the Engineering team to develop usability test plans and human factors testing that meets the various EU and US standards.
• Aid in post market surveillance for our various devices.

Requirements

• Bachelor’s degree in engineering (Biomedical, Chemical, Mechanical, Software/Computer, Electrical), science, or technical discipline with coursework in Regulatory Affairs/Quality Engineering
• 0-3 years of experience in medical device engineering/medical device regulatory affairs
• Knowledge of ISO 13485, MDD 93/42/EEC and MDR 2017/745, domestic FDA and international regulatory requirements, medical device registrations, design control activities for medical devices
• Experience with FDA and Notified Body inspections
• Experience with Class II (US)/Class I, Class II and Class III (Europe) medical devices

Job Type: Full-time

Pay: $71,000.00 - $80,000.00 per year

Experience level:

• 3 years

Experience:

• FDA regulations: 3 years (Required)
• ISO 13485: 3 years (Required)
• Regulatory Affairs: 3 years (Required)
• Quality assurance: 3 years (Required)
• Technical writing: 3 years (Required)

Work Location: In person