Regulatory Affairs Specialist in Remote at Delcath Systems Inc

POSITION SUMMARY

The Specialist, Regulatory Affairs is responsible for executing the day-to-day tactical activities of Regulatory Affairs, with specific emphasis on compiling regulatory submissions. The Specialist, Regulatory Affairs, shall provide direct regulatory submission support for CE Trademarked Device in the EU and regulatory support for NDA for our oncologic drug/device combination product that is regulated as a drug.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

Must have knowledge of Applications for FDA Approval to Market a New Drug regulations under 21 CFR 314.Must be familiar with the Quality Management System Regulations under 21 CFR 820, Regulation of Combination Products 21 CFR 4, EU Medical Device Regulation (MDR), and UK Medical Devices Regulation 2002.Must be familiar with FDA’s current thinking and guidance for industry.Execute day-to-day processes for regulatory accountabilities to ensure continual regulatory compliance with FDA and MDR requirements.Maintain the change control tracker, including documents to be included in the Annual Report.Work closely with regulatory team and internal staff to prepare and review domestic and international regulatory submissions. These shall include submissions to Medical Device Notified Body and NDA supplements and amendments thereof.Prepare NDA Annual Report for submission to FDA. Update the draft annual report on an ongoing basis, identifying updated documents that will require linking in the next Annual Report. Monitor, review, and interpret new or revised regulatory requirements.Must be able to review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; and appropriately document the regulatory disposition of such changes.Other activities as assigned by management.SUPERVISORY RESPONSIBILITIES

This position currently has no direct reports.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

A minimum of bachelor’s degree in engineering or physical sciences. Must have at least 5 years drug regulatory affairs experience in the pharmaceutical industry, with direct accountabilities related to Health Authority submissions and compliance related matters. Drug/device combination product experience a plus.Must have direct working knowledge of FDA and International drug regulations.Experience working across multi-disciplinary levels, functions and regions is required.Must be team oriented, with the ability to work well with diverse cross-functional teams.Must possess strong analytical and process skills and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.Must possess strong verbal and written communication skills.Must be willing to travel.

LANGUAGE SKILLS

Must be able to read and interpret technical documents. Must be able to effectively write routine reports and correspondence. Must possess ability to speak effectively with employees and outside organizations.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and create and/or interpret spreadsheets and graphs.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.