Regulatory Affairs Specialist

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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