Regulatory Affairs Specialist

4 weeks ago

Ithaca New York, United States KLM Careers Full time
Regulatory Affairs Specialist

Ithaca, NY

Must be a US Citizen or Green Card holder.

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.

Duties and Responsibilities

Remain current on all applicable regulatory guidances that impact the companys 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 guidances 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.

Working Relationships

The position works closely with many of Transonics key staff, such as the Regulatory & Quality Director, the rest of the Quality and Regulatory Department, the Distributor Managers, Marketing Managers and Engineering Staff.

Education and Experience

Bachelors degree in engineering (Biomedical, Chemical, Mechanical, Software/Computer, Electrical), science, or technical discipline with coursework in Regulatory Affairs/Quality Engineering - required

0-3 years of experience in medical device engineering/medical device regulatory affairs - preferred

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 - preferred

Experience with FDA and Notified Body inspections - preferred

Experience with Class II (US)/Class I, Class II and Class III (Europe) medical devices preferred

Knowledge, Skills and Abilities

Must have excellent team working/collaboration skills.

Must have excellent organizational skills.

Must be accurate in handling detailed information/data.

Must have excellent communication skills: oral and written.

Must have strong ethics and be diligent in follow up along multiple projects.

Must be able to quickly learn about the various product lines and how they function.

Must be able to work independently without close supervision.

Must be proficient in the Microsoft Suite of products.

Ability to handle multiple tasks simultaneously and ability to manage project timelines - preferred

Ability to read and interpret complex engineering and mechanical drawings and documentation - preferred

Able to interpret FDA and foreign regulatory guidance as it relates to medical devices and medical devices containing software - preferred

Supervisory Responsibilities

None

Physical Demands & Work Environment

Work environment is an open office & cubicle setting.

Position primarily requires sitting, standing, walking, stooping, reaching, and talking in an office environment.

Must adhere to safety requirements.

Required Knowledge, Skills, and Abilities: (Hiring Companies ATS Questions):

1. Do you have a Bachelor's degree in engineering (biomedical, chemical, mechanical, software, computer, electrical)

2. Are you proficient in the Microsoft Suite of products.

3. Do you have knowledge of ISO 13485 MMD93/4 and MDR 2017/745, domestic FDA and international regulatory requirements, design control activities for medical devices - preferred

4. Do you have experience with FDA and Notified Body Inspections - preferred

5. Do you have experience with Class II (US)/Class I, and Class III (Europe) medical devices. - preferred

6. Must be a US Citizen or Green Card holder.

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