Regulatory Affairs Specialist - Ithaca, United States - Synectics

Description

Full Job Description

Who we are looking for:

Our client is looking for a dynamic, critical-thinking, self-directed initiator who can be a key contributor in the company's regulatory affairs department for their medical devices, life science, and OEM markets.

The client is looking for someone with an understanding of the FDA & EU MDR requirements, as well as other key country regulatory requirements to support their worldwide product registrations.

The client is hoping for someone who thrives in a fast-paced environment while still being detail-oriented and who is able to think along with multiple projects and priorities.

Who We Are And What We Offer

Our client is a small family company of around 130 staff with big goals. Their sales/service divisions in Europe and Asia provide them with worldwide reach.

The client develops and pioneers innovative technologies and solutions, often the first of their kind, which help ensure that:

Their clinicians get the data they need to make critical decisions to improve their patient's lives,
Their researchers get the measurement solutions they need to perform better research,
Their OEM clients can improve the functionality of their devices with their measurement capabilities inside.

Several of their research and clinical products have gained worldwide gold-standard status, largely through their innovative nature, the reproducibility and accuracy of their measurements, and their robust product designs.

They support their customers with top-notch training and support materials that demonstrate a deep understanding of their technology, and they go above and beyond to teach their users best practices and to help them implement their measurements.

They are a tight-knit group with a lot of long-term staff who believe passionately in their solutions and technology and because they are small, there is a lot of room for career growth and development.

Decisions are made quickly as a group, and they work hard to make the regulatory and quality department an enjoyable place to work where staff feel that they are valued and can contribute as a part of their team.

The regulatory and quality departments work together to meet the needs of the company while striving for improvements and keeping abreast of updates in regulations and standards.

They offer competitive pay & great benefits, such as company-paid 401k contributions, full, company-paid medical insurance, paid holidays, vacation, and other benefits.

Primary Function

This position will support worldwide regulatory registrations for their current and future medical devices as well as support process compliance in conjunction with their 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 company's ability to legally market medical devices worldwide, 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 their customers during audits with regulatory agencies or notified bodies.
Support registration activities with their distribution channels through the 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 their various devices.

Working Relationships

The position works closely with many of their customer's 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

Bachelor's 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 teamwork/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
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.

Benefits

401(k)
Health insurance
On-site gym
Paid time off

Schedule

8-hour shift
Day shift
Monday to Friday

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